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NCT01218100 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension
A Phase 4 study of Stage 2 Diastolic Hypertension, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 664
- Enrollment target
- 20
- Study locations
NCT01218100: Completed Phase 4 study of Stage 2 Diastolic Hypertension, sponsored by Forest Laboratories.
NCT01218100 is a Phase 4 study of Stage 2 Diastolic Hypertension that has completed, run by Forest Laboratories. The registered enrollment target is 664 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01218100, a Phase 4 study of Stage 2 Diastolic Hypertension, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 664 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP\>= 100 mmHg).
Conditions Studied
Interventions
- DRUG placebo
- DRUG nebivolol and lisinopril (free combination)
- DRUG nebivolol monotherapy
- DRUG lisinopril monotherapy
Study Locations (20)
California
- Forest Investigative site 038 - Buena Park
- Forest Investigative site 075 - Burbank
- Forest Investigative site 042 - Costa Mesa
- Forest Investigative site 028 - Fountain Valley
- Forest Investigative site 064 - Fresno
- Forest Investigative site 079 - Lancaster
- Forest Investigative site 097 - Long Beach
- Forest Investigative site 049 - Los Angeles
- Forest Investigative site 081 - Riverside
- Forest Investigative site 040 - San Marino
- Forest Investigative site 059 - San Ramon
- Forest Investigative site 074 - Santa Ana
- Forest Investigative site 072 - Tustin
Arizona
- Forest Investigative Site #58 - Scottsdale
- Forest Investigative site 080 - Tempe
- Forest Investigative site 096 - Tucson
Florida
- Forest Investigative site 019 - Boca Raton
- Forest Investigative site 056 - Brandon
Colorado
- Forest Investigative site 077 - Colorado Springs
Connecticut
- Forest Investigative site 050 - Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 664 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
What the finished NCT01218100 record still lists
NCT01218100 is an interventional study that assigns participants to a tested intervention. The registered 664 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 (28% higher).
The record links to 1 condition, with Stage 2 Diastolic Hypertension appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT01218100 names 20 study sites across 5 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT01218100 about?
NCT01218100 is a clinical study titled "Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension". This study will evaluate the safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP\>= 100 mmHg).
What is the current status of trial NCT01218100?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 664 participants. The study started on 2010-10. Estimated completion is 2011-06.
What conditions does trial NCT01218100 study?
This clinical trial studies the following conditions: Stage 2 Diastolic Hypertension.
What interventions are being tested in trial NCT01218100?
The interventions under investigation include: placebo (DRUG), nebivolol and lisinopril (free combination) (DRUG), nebivolol monotherapy (DRUG), lisinopril monotherapy (DRUG).
Who is sponsoring clinical trial NCT01218100?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01218100 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01218100's enrollment target sits among peer trials
664 120th of 2000 higher than 1,881 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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