AgingResearch.NewsJoin free

Phase 2Active, not recruiting

A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

Sponsor
Tectonic Therapeutic (Industry)
Enrollment
191 planned
Conditions
Pulmonary Hypertension; Heart Failure With Preserved Ejection Fraction
Interventions
TX000045- Dose A; TX000045- Dose B; Placebo
Ages
adults, older adults
Registry
NCT06616974

Full record on ClinicalTrials.gov

From the registry

TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).

Primary outcomes

  • Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).
  • Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.
  • Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
  • Number of participants with treatment-related adverse events.

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Registered

  5. Started