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NCT05612035 · ClinicalTrials.gov registry record · Phase 2
Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD
A Phase 2 study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05612035 is a Phase 2 study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 120 participants, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 17 states.
The verdict
NCT05612035, a Phase 2 study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Frespaciguat
Study Locations (20)
Pennsylvania
- Temple University Hospital ( Site 0104) - Philadelphia
- UPMC Montefiore University Hospital-Department of Medicine ( Site 0149) - Pittsburgh
Texas
- UT Southwestern Medical Center ( Site 0114) - Dallas
- The University of Texas Health Science Center at Houston ( Site 0105) - Houston
Buenos Aires
- Fundación Respirar ( Site 0305) - CABA
- Centro Medico Capital ( Site 0301) - La Plata
California
- UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0110) - San Francisco
Colorado
- University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 0101) - Aurora
Florida
- Clinovation Intl. Corp. ( Site 0108) - Sebring
Illinois
- Alexian Brothers Medical Center-Pulmonary ( Site 0109) - Elk Grove Village
Iowa
- University of Iowa ( Site 0103) - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2029-10-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05612035
The ClinicalTrials.gov registry entry for NCT05612035 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (93% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05612035 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Pennsylvania, Texas, Buenos Aires.
Frequently Asked Questions
What is clinical trial NCT05612035 about?
NCT05612035 is a clinical study titled "Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD". Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.
What is the current status of trial NCT05612035?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-03-16. Estimated completion is 2029-10-07.
What conditions does trial NCT05612035 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension.
What interventions are being tested in trial NCT05612035?
The interventions under investigation include: Placebo (DRUG), Frespaciguat (DRUG).
Who is sponsoring clinical trial NCT05612035?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05612035 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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