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NCT01876368 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
A Phase 3 study of Hypertension, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 376
- Enrollment target
- 20
- Study locations
NCT01876368: Completed Phase 3 study of Hypertension, sponsored by Novartis Pharmaceuticals.
NCT01876368 is a Phase 3 study of Hypertension that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 376 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01876368, a Phase 3 study of Hypertension, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 376 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan
Primary Outcome
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.
Conditions Studied
Interventions
- DRUG LCZ696
- DRUG Olmesartan
- DRUG Placebo of LCZ696
- DRUG Placebo of Olmesartan
Study Locations (20)
California
- Novartis Investigative Site - Fair Oaks
- Novartis Investigative Site - Hawaiian Gardens
- Novartis Investigative Site - Long Beach
- Novartis Investigative Site - Los Angeles
- Novartis Investigative Site - Orangevale
- Novartis Investigative Site - Westlake Village
Georgia
- Novartis Investigative Site - Atlanta
- Novartis Investigative Site - Conyers
Illinois
- Novartis Investigative Site - Chicago
- Novartis Investigative Site - Chicago
Mississippi
- Novartis Investigative Site - Belzoni
- Novartis Investigative Site - Jackson
Oregon
- Novartis Investigative Site - Oregon City
- Novartis Investigative Site - Portland
Alabama
- Novartis Investigative Site - Birmingham
Colorado
- Novartis Investigative Site - Denver
Kansas
- Novartis Investigative Site - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 376 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
What the finished NCT01876368 record still lists
NCT01876368 is an interventional study that assigns participants to a tested intervention. The registered 376 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 4 interventions - of which LCZ696 is the first listed.
NCT01876368 names 20 study sites across 11 states, led by California, Georgia, Illinois.
Frequently Asked Questions
What is clinical trial NCT01876368 about?
NCT01876368 is a clinical study titled "Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan". This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan
What is the current status of trial NCT01876368?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 376 participants. The study started on 2013-09. Estimated completion is 2014-08.
What conditions does trial NCT01876368 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT01876368?
The interventions under investigation include: LCZ696 (DRUG), Olmesartan (DRUG), Placebo of LCZ696 (DRUG), Placebo of Olmesartan (DRUG).
Who is sponsoring clinical trial NCT01876368?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01876368 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01876368's enrollment target sits among peer trials
376 154th of 470 higher than 317 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.
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