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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Stanford University
Study ID
NCT07601295
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Arterial Hypertension (PAH)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tiprelestat (5 mg) — DRUG
    5 mg of tiprelestat in 1 mL saline administered as a daily subcutaneous injection for 168 days.
  • Placebo (1 mL 0.9% saline solution) — DRUG
    Matching 1 mL 0.9% saline solution administered as a daily subcutaneous injection for 168 days.
  • Tiprelestat (10 mg) — DRUG
    10 mg of tiprelestat in 1 mL saline administered as a daily subcutaneous injection for 168 days.

Study Details

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).

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Feb 28, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tiprelestat (5 mg)
    Participants receive tiprelestat injection daily for 168 days.
  • Experimental: Tiprelestat (10 mg)
    Participants receive tiprelestat injection daily for 168 days.
  • Placebo Comparator: Placebo (1 mL 0.9% saline solution)
    Participants receive placebo injection (matching tiprelestat) daily for 168 days.

Primary Outcome Measure

Change in Pulmonary Vascular Resistance (PVR) [ Time Frame: Baseline to week 24 ]

Locations (10)

FacilityCityStateZIPSite coordinators
The University of Arizona / Banner University Medical CenterTucsonArizona85719-
University of California, San FranciscoSan FranciscoCalifornia94143-
Stanford UniversityStanfordCalifornia94305-
University of Colorado (UCD) AnschutzAuroraColorado80045-
Harvard University / Brigham and Women's HospitalBostonMassachusetts02138-
Duke UniversityDurhamNorth Carolina27710-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Brown University/Rhode Island HospitalProvidenceRhode Island02904-
University of Texas SouthwesternDallasTexas75390-
University of WashingtonSeattleWashington98195-

Find similar trials in Tucson, AZ

By research site
The University of Arizona / Banner University Medical Center· Tucson, AZUniversity of California, San Francisco· San Francisco, CAStanford University· Stanford, CAUniversity of Colorado (UCD) Anschutz· Aurora, COHarvard University / Brigham and Women's Hospital· Boston, MADuke University· Durham, NC

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