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NCT01922089 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 498
- Enrollment target
NCT01922089: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01922089 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 498 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (274% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01922089, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 498 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.
Primary Outcome
Participants experiencing hypotension, renal dysfunction, hyperkalemia and angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving \> 160 mg of valsartan or \> 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening.
Interventions
- DRUG LCZ696
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01922089 record still lists
NCT01922089 is an interventional study that assigns participants to a tested intervention. The registered 498 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 (274% higher).
The record links to 0 conditions, and to 1 intervention - of which LCZ696 is the first listed.
NCT01922089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01922089 about?
NCT01922089 is a clinical study titled "Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients". The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.
What is the current status of trial NCT01922089?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 498 participants. The study started on 2013-11. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01922089?
The interventions under investigation include: LCZ696 (DRUG).
Who is sponsoring clinical trial NCT01922089?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01922089's enrollment target sits among peer trials
498 74th of 2000 higher than 1,927 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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