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NCT00817635 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
A Phase 2 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 155
- Enrollment target
NCT00817635: Completed Phase 2 study, sponsored by Novartis.
NCT00817635 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 155 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00817635, a Phase 2 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 155 participants
- Enrollment target
Study Summary
This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.
Primary Outcome
Arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and cou
Interventions
- DRUG LCI699
- DRUG Eplerenone
- DRUG LCI699-matching Placebo
- DRUG Eplerenone-matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2008-12-22 |
| Est. Completion | 2009-10-13 |
| Phase | Phase 2 |
What the finished NCT00817635 record still lists
NCT00817635 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 4 interventions - of which LCI699 is the first listed.
NCT00817635 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00817635 about?
NCT00817635 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension". This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.
What is the current status of trial NCT00817635?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 155 participants. The study started on 2008-12-22. Estimated completion is 2009-10-13.
What interventions are being tested in trial NCT00817635?
The interventions under investigation include: LCI699 (DRUG), Eplerenone (DRUG), LCI699-matching Placebo (DRUG), Eplerenone-matching Placebo (DRUG).
Who is sponsoring clinical trial NCT00817635?
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 NCT00817635's enrollment target sits among peer trials
155 448th of 2000 higher than 1,553 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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