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NCT00660309 · ClinicalTrials.gov registry record · Phase 4
A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus
A Phase 4 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT00660309: Completed Phase 4 study, sponsored by Novartis.
NCT00660309 is a Phase 4 study that has completed, run by Novartis. The registered enrollment target is 45 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00660309, a Phase 4 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
The study objective was to assess the effect of single and multiple doses of aliskiren on renal plasma flow, glomerular filtration rate and to compare the effects of single and multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.
Primary Outcome
Renal plasma flow (RPF) was measured by the clearance of para-aminohippurate (PAH) by autoanalyzer methods. The measure of the single dose effect (SDE) for aliskiren and irbesartan was calculated as Day 2 peak - Day 2 baseline RPF. Baseline RPF was determined as the median of the -10 minute, -5 minute predose and predose (0 hour) values. Peak RPF was obtained using a moving average concept.
Interventions
- DRUG Irbesartan
- DRUG Aliskiren
- DRUG Captopril
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 4 |
What the finished NCT00660309 record still lists
NCT00660309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Irbesartan is the first listed.
NCT00660309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00660309 about?
NCT00660309 is a clinical study titled "A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus". The study objective was to assess the effect of single and multiple doses of aliskiren on renal plasma flow, glomerular filtration rate and to compare the effects of single and multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular filtration rate, and retinal blo...
What is the current status of trial NCT00660309?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2008-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00660309?
The interventions under investigation include: Irbesartan (DRUG), Aliskiren (DRUG), Captopril (DRUG).
Who is sponsoring clinical trial NCT00660309?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00660309's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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