NCT04370873View on ClinicalTrials.gov

Frespaciguat (MK-5475) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006)

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

June 5, 2020

Primary Completion Date

January 12, 2022

Study Completion Date

January 12, 2022

Conditions
Pulmonary Hypertension
Interventions
DRUG

Frespaciguat

Frespaciguat 32 µg, 100 µg, 195 µg, 360 µg or 380 µg administered as dry powder inhalation according to randomization. Following review of pharmacokinetic (PK) and safety data, a second 7 days of dosing may be initiated. A dose of up to 360 μg up to twice a day may be administered based on PK data. Dosage may be adjusted downwards in Part 2, if indicated by PK results in Part 1.

DRUG

Placebo

Placebo administered as dry powder inhalation according to randomization

Trial Locations (9)

2025

Republican Clinical Hospital of Moldova ( Site 0013), Chisinau

14642

University of Rochester Medical Center ( Site 0012), Rochester

21205

Johns Hopkins - University ( Site 0003), Baltimore

29425

Medical Universtiy of South Carolina ( Site 0011), Charleston

40502

Lexington VA- Health Care System ( Site 0034), Lexington

3109601

Rambam Medical Center ( Site 0037), Haifa

4941492

Rabin Medical Center ( Site 0035), Petah Tikva

02114

Massachusetts General Hospital ( Site 0005), Boston

02115

Brigham & Women's Hospital ( Site 0001), Boston

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04370873 - Frespaciguat (MK-5475) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006) | Biotech Hunter | Biotech Hunter