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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: Active Phase 2 study of Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, sponsored by Merck Sharp & Dohme.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
6MWD is assessed using the 6-minute walk test (6MWT).
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 |
What the registry record for NCT05612035 still lists
NCT05612035 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (93% lower).
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 names 20 study sites across 17 states, led by 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.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease
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 NCT05612035's enrollment target sits among peer trials
120 48th of 86 higher than 39 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease 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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