RecruitingNot ApplicableNCT06968962

Comparison of Sequential to Initial Combination Therapy in PAH

A Multicenter, Randomized, Controlled, Double-blind, and Non-inferiority Clinical Trial to Compare the Efficacy of Sequential to Initial Combination Therapy in Patients With Pulmonary Arterial Hypertension


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

376 participants

Start Date

May 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, controlled, double-blind, and non-inferiority clinical trial to compare the efficacy of sequential to initial combination therapy in patients with pulmonary arterial hypertension (PAH). Ambrisentan and Tadalafil will be used in the study. Our research hypothesis is that the efficacy of sequential combination therapy in PAH patients is not inferior to the initial combination therapy as the primary efficacy endpoint is the change in 6MWD at month 12 from baseline.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different treatment approaches for pulmonary arterial hypertension (PAH) — a serious condition where blood pressure in the lungs is dangerously high — to find out whether starting with a combination of drugs from the beginning works better than adding drugs one at a time. **You may be eligible if...** - You are between 18 and 80 years old and weigh at least 40 kg - You have been diagnosed with PAH (idiopathic, hereditary, or related to conditions like scleroderma, lupus, congenital heart disease, or HIV) - Your heart and lung function fall within categories I–III on the WHO scale (mild to moderately limited) - You have not yet started or are newly starting PAH treatment **You may NOT be eligible if...** - Your PAH is caused by conditions like left heart disease, lung disease, or chronic blood clots in the lungs - You have very severe heart or liver problems - You have had a lung transplant - You are pregnant or breastfeeding - You are currently on medications that interfere with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTadalafil

Target dose 40 mg OD

DRUGAmbrisentan

Target dose 10 mg OD

DRUGAmbrisentan mimic

Ambrisentan mimic will switch to Ambrisentan if low risk status was not achived at month 4, or 8, or 12.

DRUGTadalafil mimic

Tadalafil mimic will switch to Tadalafil if low risk status was not achived at month 4, or 8, or 12.


Locations(1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06968962


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