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NCT04605549 · ClinicalTrials.gov registry record · Phase 2
A Study of CIN-107 in Adults With Primary Aldosteronism
A Phase 2 study of Primary Aldosteronism and Hyperaldosteronism, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 10
- Study locations
NCT04605549: Completed Phase 2 study of Primary Aldosteronism and Hyperaldosteronism, sponsored by AstraZeneca.
NCT04605549 is a Phase 2 study of Primary Aldosteronism and Hyperaldosteronism that has completed, run by AstraZeneca. The registered enrollment target is 15 participants, below the 3,268-participant average among 4 other Primary Aldosteronism trials with a reported enrollment target (100% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04605549, a Phase 2 study of Primary Aldosteronism and Hyperaldosteronism, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability.
Primary Outcome
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.
Conditions Studied
Interventions
- DRUG CIN-107 2 mg dosing
- DRUG CIN-107 4 mg dosing
- DRUG CIN-107 8 mg dosing
Study Locations (10)
California
- Research Site - Greenbrae
- Research Site - San Francisco
- Research Site - West Hollywood
Ohio
- Research Site - Cincinnati
- Research Site - Columbus
Illinois
- Research Site - Chicago
Maryland
- Research Site - Baltimore
Michigan
- Research Site - Ann Arbor
Minnesota
- Research Site - Rochester
Texas
- Research Site - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2024-10-28 |
| Phase | Phase 2 |
What the finished NCT04605549 record still lists
NCT04605549 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 3,268-participant average among 4 other Primary Aldosteronism trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Primary Aldosteronism appearing as the primary indexed condition, and to 3 interventions - of which CIN-107 2 mg dosing is the first listed.
NCT04605549 lists 10 locations in 7 states (California, Ohio, Illinois).
Frequently Asked Questions
What is clinical trial NCT04605549 about?
NCT04605549 is a clinical study titled "A Study of CIN-107 in Adults With Primary Aldosteronism". This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability.
What is the current status of trial NCT04605549?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2021-03-08. Estimated completion is 2024-10-28.
What conditions does trial NCT04605549 study?
This clinical trial studies the following conditions: Primary Aldosteronism, Hyperaldosteronism.
What interventions are being tested in trial NCT04605549?
The interventions under investigation include: CIN-107 2 mg dosing (DRUG), CIN-107 4 mg dosing (DRUG), CIN-107 8 mg dosing (DRUG).
Who is sponsoring clinical trial NCT04605549?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04605549 being conducted?
This trial has 10 study locations across California, Illinois, Maryland, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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