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NCT01692301 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension
A Phase 2 study of Hypertension, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 454
- Enrollment target
- 20
- Study locations
NCT01692301: Completed Phase 2 study of Hypertension, sponsored by Novartis Pharmaceuticals.
NCT01692301 is a Phase 2 study of Hypertension that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 454 participants, below the 3,506-participant average among 470 other Hypertension trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01692301, a Phase 2 study of Hypertension, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 454 participants
- Enrollment target
- 20
- Study locations
Study Summary
The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).
Primary Outcome
Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software. At the first study visit, the arm with the highest systo
Conditions Studied
Interventions
- DRUG LCZ696
- DRUG Olmesartan
- DRUG LCZ696 matching placebo
- DRUG Olmesartan matching placebo
- DRUG amlodipine
Study Locations (20)
Other
- Novartis Investigative Site - Barranquilla
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Berlin
- Novartis Investigative Site - Nuremberg
Texas
- Novartis Investigative Site - Houston
- Novartis Investigative Site - Lake Jackson
- Novartis Investigative Site - Pasadena
Mississippi
- Novartis Investigative Site - Belzoni
- Novartis Investigative Site - Jackson
Buenos Aires
- Novartis Investigative Site - Caba
- Novartis Investigative Site - Ramos Mejía
Florida
- Novartis Investigative Site - Clearwater
Illinois
- Novartis Investigative Site - Chicago
Maryland
- Novartis Investigative Site - Baltimore
Missouri
- Novartis Investigative Site - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
What the finished NCT01692301 record still lists
NCT01692301 is an interventional study that assigns participants to a tested intervention. The registered 454 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 (87% lower).
The record links to 1 condition, with Hypertension appearing as the primary indexed condition, and to 5 interventions - of which LCZ696 is the first listed.
NCT01692301 names 20 study sites across 13 states, led by Other, Texas, Mississippi.
Frequently Asked Questions
What is clinical trial NCT01692301 about?
NCT01692301 is a clinical study titled "Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension". The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).
What is the current status of trial NCT01692301?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 454 participants. The study started on 2012-12. Estimated completion is 2015-04.
What conditions does trial NCT01692301 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT01692301?
The interventions under investigation include: LCZ696 (DRUG), Olmesartan (DRUG), LCZ696 matching placebo (DRUG), Olmesartan matching placebo (DRUG), amlodipine (DRUG).
Who is sponsoring clinical trial NCT01692301?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01692301 being conducted?
This trial has 20 study locations across Florida, Illinois, Maryland, Mississippi, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01692301's enrollment target sits among peer trials
454 134th of 470 higher than 336 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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