This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease (NCT00296374), a randomized phase 2 study. The primary outcome is Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00296374 |
| Phase | Phase 2 |
| Condition | Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 353 |
| Arms in the primary outcome | 3 |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
People with Type 1 or Type 2 diabetes, moderate proteinuria, and hypercholesterolaemia were the intended population. The registry record lists Diabetes Mellitus as the condition and gives total enrollment as 353. Further eligibility details are not reported in the registry record.
Intervention
The study assigned participants to rosuvastatin 10 mg or rosuvastatin 40 mg. The official title describes a 52-week study, and the primary outcome was assessed at Week 52 using last observation carried forward.
Comparator
The registry designates rosuvastatin 10 mg as the reference arm for the posted outcome data. The third arm received atorvastatin 80 mg. The registry record lists no placebo or untreated arm.
Primary question
The main question was how the Week 52 urinary protein/creatinine ratio relative to baseline was distributed in each treatment arm. The endpoint is a ratio of follow-up to baseline measurements, reported as a geometric mean with a 95% confidence interval. Arm-level values are posted, but a formal sponsor-reported statistical comparison among the three arms is not reported in the registry record.
The study was designed around urinary protein excretion in people with diabetes and kidney disease features. Protein/creatinine is a urine measure that expresses protein concentration relative to creatinine concentration. This ratio is used to characterize urinary protein excretion while accounting for variation in urine concentration. The posted primary outcome is not an absolute protein concentration: it describes the Week 52 ratio relative to the baseline ratio. Its interpretation therefore concerns change from baseline within each arm, rather than a direct estimate of the difference between any two treatments.
3. Trial Design
The registry describes a randomized, parallel-group study with quadruple masking. Its official title calls it a double-blind, multicentre, 52-week, Phase IIb study; the phase field lists Phase 2. The record lists three active treatment arms: rosuvastatin 10 mg, rosuvastatin 40 mg, and atorvastatin 80 mg. Random allocation is recorded, but the allocation procedure, concealment details, and the identity of all parties covered by quadruple masking are not reported in the registry record.
Total enrollment was 353. The available primary outcome data include 107 participants in the rosuvastatin 10 mg arm, 116 in the rosuvastatin 40 mg arm, and 102 in the atorvastatin 80 mg arm. These are the outcome-specific counts, and they should not be treated as a full description of the analysis populations or as a reconciliation of all enrolled participants. The registry record does not report reasons for differences in participant counts across outcomes.
The study began in 2006-02, had primary completion in 2009-03, and is listed as completed. The primary endpoint was assessed at Week 52 using last observation carried forward. Secondary outcomes included urinary protein and albumin ratios, estimated glomerular filtration rate, and measures concerning relationships between renal outcomes and lipid changes. The registry record lists 72 outcome measures, including 71 secondary outcomes. It does not report a sample-size justification, the planned primary comparison, or a detailed statistical analysis plan. Those omissions limit how fully the design rationale and intended inferential framework can be reconstructed from the record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Patients requiring an adjustment of the ACE inhibitor and/or ARBs after Visit 1 were excluded. All 353 patients were randomized and 276 patients completed the study.
Overall Study
| Stage | Rosuvastatin 10mg | Rosuvastatin 40mg | Atorvastatin 80mg |
|---|---|---|---|
| STARTED | 118 | 124 | 111 |
| COMPLETED | 93 | 101 | 82 |
| NOT COMPLETED | 25 | 23 | 29 |
Reasons for not completing this period:
| Reason | Rosuvastatin 10mg | Rosuvastatin 40mg | Atorvastatin 80mg |
|---|---|---|---|
| Adverse Event | 14 | 10 | 7 |
| Withdrawal by Subject | 3 | 5 | 11 |
| Incorrect enrollment | 3 | 3 | 4 |
| Protocol Violation | 1 | 2 | 3 |
| Lost to Follow-up | 3 | 1 | 1 |
| Relocated to another state | 1 | 0 | 0 |
| Stopped drug before end of study visit | 0 | 1 | 0 |
| Nephrologist introduced ACE | 0 | 1 | 0 |
| Pregnancy | 0 | 0 | 2 |
| Other | 0 | 0 | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Rosuvastatin 10mg | Rosuvastatin 40mg | Atorvastatin 80mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 118 | 124 | 111 | 353 | |
| Age, Customized: 18-49 years | Participants | 22 | 33 | 25 | 80 |
| Age, Customized: 50-64 years | Participants | 59 | 59 | 57 | 175 |
| Age, Customized: >=65 years | Participants | 37 | 32 | 29 | 98 |
| Sex: Female, Male: Female | Participants | 43 | 32 | 33 | 108 |
| Sex: Female, Male: Male | Participants | 75 | 92 | 78 | 245 |
| Estimated glomerular filtration rate [eGFR] | mL/min | 68.759 (SD 24.1080) | 72.644 (SD 25.8018) | 72.149 (SD 24.8721) | 71.210 (SD 24.9455) |
| Urine albumin/creatinine ratio | mg/g | 1036.478 (SD 730.6185) | 1079.802 (SD 725.7039) | 1143.198 (SD 779.5282) | 1085.435 (SD 743.5360) |
| Urine protein/creatinine ratio | mg/g | 1392.26 (SD 888.3215) | 1493.574 (SD 996.0972) | 1517.858 (SD 969.7020) | 1467.843 (SD 952.0380) |
6. Primary Endpoint
The registry lists the primary outcome as Urinary Protein/Creatinine Ratio in Patients With Type 1 or 2 Diabetes., measured over Assessed at Week 52, Last observation carried forward (LOCF).
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mg/g |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the ratio of the urinary protein/creatinine ratio at Week 52 to the corresponding baseline ratio. The registry defines urinary protein/creatinine as urine protein concentration divided by urine creatinine concentration. It reports the endpoint as a geometric mean with a 95% confidence interval and uses last observation carried forward for the Week 52 assessment.
A ratio of follow-up to baseline expresses the follow-up measurement in relation to each participant’s starting measurement. Values near the point of no change indicate that follow-up and baseline ratios are similar; values below that point indicate a lower follow-up ratio, and values above it indicate a higher follow-up ratio. This relative scale can be useful when participant measurements vary widely and the outcome is naturally expressed multiplicatively. A geometric mean is suited to that scale because it summarizes ratios on a multiplicative basis rather than as an arithmetic average of raw measurements.
Urinary protein excretion is used as an indicator of protein passing into the urine. The creatinine adjustment helps account for urine concentration, which can vary between samples. The endpoint therefore offers a standardized measure of urinary protein relative to baseline, but it is not itself a direct measure of kidney function or a complete account of a participant’s clinical status. The registry record does not report further details on the endpoint’s clinical threshold or on how changes of different sizes were expected to be interpreted.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary results are arm-specific geometric mean ratios. For rosuvastatin 10 mg, the reported value was 1.016, with a 95% confidence interval from 0.858 to 1.209. For rosuvastatin 40 mg, it was 0.955, with a 95% confidence interval from 0.869 to 1.185. For atorvastatin 80 mg, it was 0.874, with a 95% confidence interval from 0.733 to 0.975. These estimates describe the Week 52 urinary protein/creatinine ratio relative to baseline under the registry’s last-observation-carried-forward approach.
The rosuvastatin arm intervals extend across the point corresponding to no change from baseline. The atorvastatin arm interval lies below that point. This describes the location and uncertainty of each arm’s estimate; it is not a formal test of whether one treatment differs from another. The registry record does not report a sponsor-conducted primary comparison, a p-value for the primary outcome, or a treatment-effect estimate comparing arms. Thus, the arm-level pattern alone cannot establish the statistical evidence for a difference between treatments.
The confidence intervals also indicate that the arm estimates are not exact. They express a range of values compatible with the observed data under the assumptions used to construct the intervals. Overlap among arm-level confidence intervals is not a substitute for a direct comparison: a treatment contrast has its own estimate and uncertainty, and those are not reported for the primary outcome. The record also does not describe any adjustment for baseline characteristics or other covariates in the primary analysis.
The primary outcome population counts were 107, 116, and 102, respectively. These outcome counts are not the same as the overall enrollment of 353, and the record does not explain participant flow into the primary analysis. Because the endpoint uses last observation carried forward, the Week 52 value may include carried-forward measurements rather than observations collected at that visit for every participant. The extent of this imputation and its consequences are not reported in the registry record.
The outcome is specifically a urinary protein/creatinine ratio, not a broad measure of renal function. Other posted outcomes concern estimated glomerular filtration rate and urinary albumin/creatinine, among other measures, but those do not replace the primary endpoint. Each measure addresses a different aspect of renal status, and their results should be interpreted according to their own definitions, time points, and analysis methods. Overall, the primary results describe the observed arm-level ratios and their precision; they do not by themselves establish comparative benefit, harm, or clinical importance.
9. Statistical Methods Explained
The registry reports a geometric mean for the primary endpoint and a 95% confidence interval. The endpoint itself is a ratio: the Week 52 urinary protein/creatinine ratio divided by the baseline ratio. Statistical interpretation should therefore follow the relative, multiplicative scale of the measure rather than treating it as a raw urine protein concentration.
What does a geometric mean ratio convey?
For a ratio-based outcome, a geometric mean summarizes the central tendency after accounting for the multiplicative nature of the values. A value at the no-change point corresponds to similar follow-up and baseline ratios. A value below it corresponds to a lower follow-up ratio, while a value above it corresponds to a higher follow-up ratio. The reported estimates are 1.016 for rosuvastatin 10 mg, 0.955 for rosuvastatin 40 mg, and 0.874 for atorvastatin 80 mg. These are within-arm summaries of the Week 52-to-baseline ratio, not estimates of between-arm differences.
How should the confidence intervals be read?
A confidence interval communicates uncertainty around an estimate. It is not a range containing every participant’s measurement, and it is not a probability statement about a particular treatment effect. The primary 95% confidence intervals are 0.858 to 1.209 for rosuvastatin 10 mg, 0.869 to 1.185 for rosuvastatin 40 mg, and 0.733 to 0.975 for atorvastatin 80 mg. The first two intervals include the no-change point for the ratio; the last does not. This within-arm observation does not test whether the arms differ. A direct treatment comparison needs its own contrast and uncertainty estimate.
Confidence intervals can be used to judge precision as well as direction. Wider intervals indicate less precision than narrower intervals, all else equal. Precision depends on factors such as variability, sample size, and the analysis method. The registry record does not report the calculation method for the primary confidence intervals, so their construction cannot be independently assessed from the record alone.
What is the role of the comparator arm?
Rosuvastatin 10 mg is the registry-designated reference arm for the posted outcome data. Comparisons of rosuvastatin 40 mg or atorvastatin 80 mg with that reference would require estimates of differences between arms, together with their uncertainty and an appropriate statistical test. The primary outcome record supplies arm-level geometric means and intervals but does not report these comparative estimates. It would therefore be inappropriate to infer a treatment contrast merely by subtracting or otherwise comparing the displayed arm summaries.
General statistical principle: a direct comparison uses the distribution of the outcome in both arms and accounts for uncertainty in each. Comparing whether separate confidence intervals cross a reference value does not provide the same information as testing a treatment contrast. The distinction matters particularly when several active regimens are studied and the registry does not specify which comparison was intended as the main inferential test.
What does last observation carried forward mean?
Last observation carried forward is an imputation approach in which an earlier recorded measurement is used in place of a missing later measurement. The primary endpoint is explicitly identified as Week 52 with last observation carried forward. This method produces a Week 52 analysis value even when the Week 52 observation is unavailable, but it relies on an assumption that carrying an earlier value forward is an acceptable representation of the later value. That assumption may not fit every participant’s trajectory. The registry record does not report the amount or pattern of missing Week 52 data, the timing of carried-forward observations, or sensitivity analyses using alternative missing-data methods.
General statistical principle: missing-data assumptions can influence estimates and uncertainty, especially when missingness is related to participants’ outcomes or treatment experience. Different assumptions can lead to different results. The record does not provide enough information to evaluate whether the chosen imputation approach was robust in this study.
How should secondary comparisons be understood?
The posted eGFR summaries include means, standard deviations, and recalculated unadjusted pairwise comparisons against rosuvastatin 10 mg. These recalculations are based on posted summary statistics; they are not sponsor-reported analyses. For Week 26, the recalculated mean difference for rosuvastatin 40 mg was -2.73, with p = 0.138, and for atorvastatin 80 mg it was 0.95, with p = 0.578. For Week 52, the corresponding estimates were -3.59, with p = 0.125, and 2.09, with p = 0.27. The reported unadjusted p-values do not account for testing multiple outcomes or comparisons.
General statistical principle: a p-value describes how incompatible the observed data are with a specified null model, conditional on the analysis assumptions. It does not measure the size or clinical importance of an effect, and it does not give the probability that the null hypothesis is true. Confidence intervals are useful alongside p-values because they show the range of estimates compatible with the data under the analysis assumptions. The secondary comparisons are exploratory in this context because the registry does not report a prespecified hierarchy, multiplicity procedure, or sponsor-reported inferential analyses.
Planning illustrations based on observed effects are not evidence that the completed study had a specified probability of detecting an effect. Such calculations are prospective design scenarios that depend on their assumptions, including the effect targeted and allocation. The registry record says the illustrations use a two-sided significance level of 0.05, equal allocation, and a normal approximation. They are not the trial’s sample-size justification, and they are not observed power. The trial’s own sample-size assumptions and justification are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists many outcomes, but it does not report how the investigators handled multiplicity. In a study with several treatment arms, time points, and outcome measures, multiple statistical tests can increase the chance that at least one result appears notable even when no real difference exists. A prespecified hierarchy, adjustment procedure, or distinction between confirmatory and exploratory outcomes can help readers assess that risk. Such details are not reported in the registry record.
The primary results are arm-level geometric means and confidence intervals. A sponsor-reported formal comparison for the primary outcome, including a p-value or comparative confidence interval, is not reported in the registry record. For the posted secondary eGFR summaries, the pairwise comparisons are recalculated from summary statistics and are unadjusted. No sponsor-reported analyses are listed for those outcomes. These recalculations should not be mistaken for the trial’s original analysis plan or for multiplicity-controlled tests.
Missing-data handling is stated for the primary outcome: Week 52 values use last observation carried forward. The registry record does not report the number of missing observations, the reasons for missingness, the pattern of missing data by arm, or sensitivity analyses. It also does not state whether the secondary outcomes used the same approach. Without those details, the effect of missing-data assumptions on the results cannot be assessed.
The record does not report the analysis populations, such as whether the primary analysis included all randomized participants or a subset defined by treatment received or data availability. Although the outcome-specific arm counts are posted, those counts alone do not establish the analysis population. The handling of protocol deviations, treatment discontinuation, and participants with incomplete follow-up is also not reported in the registry record. These omissions limit assessment of how closely the analyzed groups preserve the benefits of random allocation.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Rosuvastatin 10mg | 18 | 116 | 15.5% |
| Rosuvastatin 40mg | 20 | 123 | 16.3% |
| Atorvastatin 80mg | 21 | 110 | 19.1% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Rosuvastatin 10mg | 15 of 116 |
| Rosuvastatin 40mg | 25 of 123 |
| Atorvastatin 80mg | 12 of 110 |
Most frequent serious adverse event terms
| Event term | Organ system | Rosuvastatin 10mg | Rosuvastatin 40mg | Atorvastatin 80mg |
|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | 3 of 116 | 1 of 123 | 1 of 110 |
| Angina Pectoris | Cardiac disorders | 2 of 116 | 1 of 123 | 2 of 110 |
| Acute Myocardial Infarction | Cardiac disorders | 1 of 116 | 0 of 123 | 1 of 110 |
| Oedema Peripheral | General disorders | 2 of 116 | 0 of 123 | 0 of 110 |
| Death | General disorders | 1 of 116 | 1 of 123 | 0 of 110 |
| Gangrene | Infections and infestations | 0 of 116 | 1 of 123 | 1 of 110 |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | 0 of 116 | 0 of 123 | 2 of 110 |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | 1 of 116 | 1 of 123 | 0 of 110 |
| Hyperglycaemia | Metabolism and nutrition disorders | 0 of 116 | 1 of 123 | 1 of 110 |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | 0 of 116 | 0 of 123 | 2 of 110 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Rosuvastatin 10mg | Rosuvastatin 40mg | Atorvastatin 80mg |
|---|---|---|---|---|
| Oedema Peripheral | General disorders | 9 of 116 | 5 of 123 | 3 of 110 |
| Myalgia | Musculoskeletal and connective tissue disorders | 3 of 116 | 6 of 123 | 7 of 110 |
| Hypertension | Vascular disorders | 2 of 116 | 8 of 123 | 2 of 110 |
| Influenza | Infections and infestations | 3 of 116 | 7 of 123 | 0 of 110 |
Serious events with the highest arm-level rate: cardiac failure (2.6%), angina pectoris (1.8%), diabetes mellitus inadequate control (1.8%), abortion spontaneous (1.8%), oedema peripheral (1.7%).
The registry reports serious adverse events and other adverse events as counts of affected participants alongside the number at risk in each arm. For serious adverse events, the recorded figures are 18 of 116 for rosuvastatin 10 mg, 20 of 123 for rosuvastatin 40 mg, and 21 of 110 for atorvastatin 80 mg. For other adverse events, the figures are 15 of 116, 25 of 123, and 12 of 110, respectively. These are arm-level registry counts; they do not by themselves establish whether an event was caused by treatment.
The listed serious-event terms include Cardiac Failure at 2.6%, Angina Pectoris at 1.8%, Diabetes Mellitus Inadequate Control at 1.8%, Abortion Spontaneous at 1.8%, Oedema Peripheral at 1.7%, and Renal Failure Acute at 1.6%. The record does not provide enough detail in these summary figures to interpret the listed terms as comparative treatment effects. Death counts are not reported in the registry record.
These safety counts should be read descriptively. The registry record does not report exposure-adjusted rates, event timing, severity distributions beyond the serious-event classification, or a statistical comparison between arms. It also does not identify causal attribution in these figures. Consequently, differences in counts should not be interpreted as proof of a treatment-related safety difference.
12. What the Result Does, and Does Not, Mean
The posted primary results describe the Week 52 urinary protein/creatinine ratio relative to baseline in each treatment arm, with the uncertainty captured by 95% confidence intervals. The rosuvastatin 10 mg and rosuvastatin 40 mg intervals extend across the no-change point, while the atorvastatin 80 mg interval lies below it. This is a description of arm-level estimates, not evidence from a formal comparison showing that one regimen differs from another.
The endpoint also has a limited scope. It measures a urine protein ratio, not kidney function as a whole, not progression to a clinical event, and not participants’ overall health. The secondary outcomes offer other measurements, but each has its own definition and limitations. The registry record does not report a treatment-effect threshold for clinical importance, so the clinical relevance of the numerical estimates cannot be determined from these values alone.
These data do not establish that a treatment works or does not work. They do not demonstrate that one regimen is superior, equivalent, or non-inferior to another. Such conclusions require an appropriate, prespecified comparison and sufficiently precise results interpreted in the context of the study design. The primary comparative analysis and its statistical plan are not reported in the registry record.
The findings also should not be generalized beyond the population and circumstances represented by the trial without further evidence. The registry describes people with Type 1 or Type 2 diabetes, moderate proteinuria, and hypercholesterolaemia, but detailed eligibility criteria are not reported. The results concern the stated outcome and follow-up assessment, with last observation carried forward for the primary endpoint. They do not answer questions about outcomes or populations that the record does not describe.
13. Why This Trial Matters Statistically
This study raises several statistical issues that matter for interpreting clinical-trial results. First, the primary endpoint is a ratio of follow-up to baseline, summarized by a geometric mean. That requires readers to distinguish a relative outcome from an absolute concentration and a within-arm summary from a between-arm treatment effect. Confusing these quantities can make an arm-level estimate appear to answer a comparative question that it does not answer.
Second, the trial has three active treatment arms, but the registry reports no sponsor-conducted primary comparison. The designated reference arm identifies how the posted outcome data are organized, but it does not establish the exact inferential contrast or analysis plan. A comparative estimate with its uncertainty would be needed to quantify how the arms differ statistically.
Third, multiple outcomes and time points create an interpretive challenge. The registry lists 72 outcome measures, including 71 secondary outcomes, while the multiplicity strategy is not reported. Secondary results can be valuable for context, but unadjusted recalculations should not be treated as confirmatory evidence. The absence of a reported analysis hierarchy makes it difficult to distinguish planned key tests from exploratory examination.
Finally, the primary use of last observation carried forward makes missing-data assumptions important. The record does not report how much data were carried forward or whether alternative assumptions were examined. The outcome counts, overall enrollment, and absence of a stated analysis population also leave participant inclusion difficult to assess. These are not reasons to discard the posted estimates; they are reasons to interpret their precision and inferential scope cautiously.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific limitations arise from what the registry record does and does not report. The primary endpoint is presented by arm, but no sponsor-reported primary contrast is available. As a result, the posted primary estimates do not directly quantify the difference between rosuvastatin 10 mg and either of the other regimens. The registry also does not report the prespecified primary hypothesis or confirmatory analysis plan.
The primary outcome uses last observation carried forward, but the amount and distribution of missing data are not reported. Without those details, readers cannot assess whether the imputed observations differ substantially by arm or whether the method’s assumptions are plausible. The record does not report sensitivity analyses that could show whether the conclusions change under alternative missing-data assumptions.
Although enrollment is listed as 353, the outcome-specific arm counts do not account for all enrolled participants. The registry record does not explain the participant flow, the analysis population, or exclusions from each outcome. It also does not report adherence, treatment discontinuations, or protocol deviations in the information summarized for these results.
The record lists numerous outcomes and time points, but does not report a multiplicity strategy. The secondary pairwise eGFR estimates are unadjusted recalculations from summary data, not sponsor-reported analyses. Finally, the safety summary provides affected-participant counts and selected serious-event terms, but does not report exposure-adjusted rates, timing, or causal attribution. These reporting gaps constrain comparative interpretation; they do not establish that an unreported method or analysis was absent from the conduct of the study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Prospective Evaluation of Proteinuria and Renal Function in Diabetic Patients With Progressive Renal Disease — NCT00296374.
- Registry record last updated 2011-09-01; status last verified 2011-08.
- Results first posted 2010-12-30.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00296374 is a completed randomized, parallel-group Phase 2 study of rosuvastatin 10 mg, rosuvastatin 40 mg, and atorvastatin 80 mg in people with diabetes and moderate proteinuria. The official title describes a double-blind, multicentre, 52-week Phase IIb study; the registry lists quadruple masking. Enrollment was 353.
The primary outcome was the Week 52 urinary protein/creatinine ratio relative to baseline, analyzed with last observation carried forward and reported as a geometric mean with a 95% confidence interval. The registry posts arm-level estimates but no sponsor-reported primary treatment comparison. Secondary outcomes cover urinary measures, eGFR, and relationships with lipid changes. The registry record does not report the statistical analysis plan, multiplicity approach, or analysis populations.