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Tiprelestat Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)

NCT07601295 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-22

No results posted yet for this study

Summary

The primary objective of this study is to compare the efficacy, safety, and tolerability of tiprelestat plus Standard of Care (SOC) compared with placebo plus SOC in patients with World Health Organization (WHO) functional class II-IV pulmonary arterial hypertension (PAH).

Conditions

  • Pulmonary Arterial Hypertension (PAH)

Interventions

DRUG

Tiprelestat (5 mg)

5 mg of tiprelestat in 1 mL saline administered as a daily subcutaneous injection for 168 days.

DRUG

Placebo (1 mL 0.9% saline solution)

Matching 1 mL 0.9% saline solution administered as a daily subcutaneous injection for 168 days.

DRUG

Tiprelestat (10 mg)

10 mg of tiprelestat in 1 mL saline administered as a daily subcutaneous injection for 168 days.

Sponsors & Collaborators

Principal Investigators

  • Roham T Zamanian, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-02-28
Completion
2030-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07601295 on ClinicalTrials.gov