NCT06616974Phase 2Active not recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2026-11-24Estimated

Enrollment · participants191Estimated

Source updated2026-07-07Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-07 · 3 fields changed

Planned enrollment increased by 11 participants

− Before

~~180 participants (planned)~~

+ After

191 participants (planned)

Primary completion date changed

− Before

~~9 Oct 2026~~

+ After

24 Nov 2026

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Study details

Conditions studied

Pulmonary Hypertension; Heart Failure With Preserved Ejection Fraction

Treatments or interventions studied

TX000045- Dose ADrug
TX000045- Dose BDrug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).; description: Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo.; timeFrame: Baseline up to Week 24 post first dose; measure: Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.; timeFrame: Baseline up to Week 30 post first dose; measure: Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.; timeFrame: Baseline up to Week 30 post first dose; measure: Number of participants with treatment-related adverse events.; timeFrame: Baseline up to Week 30 post first dose; measure: Number of participants with changes in the physical examination findings.; timeFrame: Baseline to Week 30 post first dose

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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