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NCT04936035 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension
A Phase 2 study of Hypertension, sponsored by Alnylam Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 394
- Enrollment target
- 20
- Study locations
NCT04936035: Completed Phase 2 study of Hypertension, sponsored by Alnylam Pharmaceuticals.
NCT04936035 is a Phase 2 study of Hypertension that has completed, run by Alnylam Pharmaceuticals. The registered enrollment target is 394 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 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04936035, a Phase 2 study of Hypertension, has completed, sponsored by Alnylam Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 394 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the effect of ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.
Primary Outcome
24-hour ABPM was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33, 2. the number of successful nighttime readings were ≥11, 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly mean
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALN-AGT01
Study Locations (20)
Florida
- Clinical Trial Site - Clearwater
- Clinical Trial Site - Coral Gables
- Clinical Trial Site - Fleming Island
- Clinical Trial Site - Hollywood
- Clinical Trial Site - Hollywood
- Clinical Trial Site - Inverness
- Clinical Trial Site - Jacksonville
- Clinical Trial Site - Jacksonville
- Clinical Trial Site - Jacksonville
- Clinical Trial Site - Miami
California
- Clinical Trial Site - Beverly Hills
- Clinical Trial Site - La Mesa
- Clinical Trial Site - Los Angeles
- Clinical Trial Site - San Diego
- Clinical Trial Site - South Gate
- Clinical Trial Site - Vista
Arizona
- Clinical Trial Site - Tempe
- Clinical Trial Site - Tempe
Alabama
- Clinical Trial Site - Birmingham
District of Columbia
- Clinical Trial Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2021-07-07 |
| Est. Completion | 2024-12-05 |
| Phase | Phase 2 |
What the finished NCT04936035 record still lists
NCT04936035 is an interventional study that assigns participants to a tested intervention. The registered 394 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 2 interventions - of which Placebo is the first listed.
NCT04936035 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04936035 about?
NCT04936035 is a clinical study titled "A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension". The purpose of this study is to evaluate the effect of ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.
What is the current status of trial NCT04936035?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 394 participants. The study started on 2021-07-07. Estimated completion is 2024-12-05.
What conditions does trial NCT04936035 study?
This clinical trial studies the following conditions: Hypertension.
What interventions are being tested in trial NCT04936035?
The interventions under investigation include: Placebo (DRUG), ALN-AGT01 (DRUG).
Who is sponsoring clinical trial NCT04936035?
This trial is sponsored by Alnylam Pharmaceuticals, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04936035 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04936035's enrollment target sits among peer trials
394 149th of 470 higher than 322 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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