At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
Frespaciguat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Assess the Effect of Single Doses of MK-5475 on Pulmonary Vascular Resistance in Patients With Moderate to Severe Pulmonary Arterial Hypertension
In Brief
A Phase 1 clinical trial evaluating Frespaciguat and Placebo for Pulmonary Arterial Hypertension. Completed, enrolled 25 participants across 1 site.
Detailed Summary
This study of frespaciguat in participants with Group 1 pulmonary arterial hypertension (PAH) will assess the safety, tolerability and pharmacokinetics (PK) of inhaled frespaciguat. There is no formal hypothesis to be tested.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesMoldova
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartJan 2019
Primary CompletionDec 2020
TodayJul 2026
First PostedNov 16, 2018
Enrollment StartJan 18, 2019
Primary CompletionDec 11, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.6 years ago
Interventions
Frespaciguatdrug
Single inhaled dose of frespaciguat 120, 165, 240, 300, 360, or 480 ug depending upon randomization
Placebodrug
Single inhaled dose of placebo to match frespaciguat