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NCT00631917 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
A Phase 4 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 4
- Development phase
- 774
- Enrollment target
NCT00631917: Completed Phase 4 study, sponsored by Novartis.
NCT00631917 is a Phase 4 study that has completed, run by Novartis. The registered enrollment target is 774 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00631917, a Phase 4 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 774 participants
- Enrollment target
Study Summary
This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.
Primary Outcome
The primary analysis variable was the occurrence of an abnormal colonoscopy finding (defined as hyper-plastic polyps, inflammatory polyps, adenomatous polyps or carcinoma) at or prior to the planned one year visit. The occurrence of colonic pathology was identified during colonoscopy and histopathologic examination of biopsy. The composite endpoint was evaluated after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen.
Interventions
- DRUG Ramipril
- DRUG Aliskiren
- OTHER Placebo to Ramipril
- OTHER Placebo to Aliskiren
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 774 participants |
| Start Date | 2008-02 |
| Est. Completion | 2009-09 |
| Phase | Phase 4 |
What the finished NCT00631917 record still lists
NCT00631917 is an interventional study that assigns participants to a tested intervention. The registered 774 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 4 interventions - of which Ramipril is the first listed.
NCT00631917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00631917 about?
NCT00631917 is a clinical study titled "A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension". This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.
What is the current status of trial NCT00631917?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 774 participants. The study started on 2008-02. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00631917?
The interventions under investigation include: Ramipril (DRUG), Aliskiren (DRUG), Placebo to Ramipril (OTHER), Placebo to Aliskiren (OTHER).
Who is sponsoring clinical trial NCT00631917?
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 NCT00631917's enrollment target sits among peer trials
774 105th of 2000 higher than 1,896 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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