Comparison of Sequential to Initial Combination Therapy in PAH

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.

Conditions

• Pulmonary Arterial Hypertension (PAH)

Interventions

DRUG

Tadalafil

Target dose 40 mg OD

DRUG

Ambrisentan

Target dose 10 mg OD

DRUG

Ambrisentan mimic

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

DRUG

Tadalafil mimic

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

Sponsors & Collaborators

• Huzhou Central Hospital

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• First Affiliated Hospital of Ningbo University

  collaborator NETWORK

• Ningbo No.2 Hospital

  collaborator OTHER

• Affiliated Hospital of Jiaxing University

  collaborator OTHER

• The Second Affiliated Hospital of Jiaxing University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Shanghai Pulmonary Hospital affiliated to Tongji University

  collaborator UNKNOWN

• Taizhou Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-14

Primary Completion

2028-05-31

Completion

2028-12-31

Countries

• China

Study Locations