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NCT01415531 · ClinicalTrials.gov registry record · Phase 4
Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)
A Phase 4 study of Hypertension, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 641
- Enrollment target
- 20
- Study locations
NCT01415531: Completed Phase 4 study of Hypertension, sponsored by Forest Laboratories.
NCT01415531 is a Phase 4 study of Hypertension that has completed, run by Forest Laboratories. The registered enrollment target is 641 participants, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01415531, a Phase 4 study of Hypertension, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 641 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.
Primary Outcome
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nebivolol
Study Locations (20)
California
- Forest Investigative Site 049 - Buena Park
- Forest Investigative Site 034 - Burbank
- Forest Investigative Site 039 - Costa Mesa
- Forest Investigative Site 024 - Fountain Valley
- Forest Investigative Site 020 - Fresno
- Forest Investigative Site 021 - Fresno
- Forest Investigative Site 040 - Greenbrae
- Forest Investigative Site 047 - La Mesa
- Forest Investigative Site 073 - Los Angeles
- Forest Investigative Site 077 - Roseville
- Forest Investigative Site 060 - San Bernardino
- Forest Investigative Site 054 - San Francisco
- Forest Investigative Site 018 - Spring Valley
Arizona
- Forest Investigative Site 065 - Phoenix
- Forest Investigative Site 067 - Phoenix
- Forest Investigative Site 070 - Phoenix
Florida
- Forest Investigative Site 059 - Brooksville
- Forest Investigative Site 033 - Fort Lauderdale
- Forest Investigative Site 006 - Hallandale
Colorado
- Forest Investigative Site 028 - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 641 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
What the finished NCT01415531 record still lists
NCT01415531 is an interventional study that assigns participants to a tested intervention. The registered 641 participants enrollment target is mid-sized for trials with a published cap, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01415531 names 20 study sites across 4 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT01415531 about?
NCT01415531 is a clinical study titled "Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)". The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.
What is the current status of trial NCT01415531?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 641 participants. The study started on 2011-08. Estimated completion is 2012-04.
What conditions does trial NCT01415531 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT01415531?
The interventions under investigation include: Placebo (DRUG), Nebivolol (DRUG).
Who is sponsoring clinical trial NCT01415531?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01415531 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01415531's enrollment target sits among peer trials
641 99th of 470 higher than 372 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension 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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