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Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension

NCT04972656 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2022-09-28

No results posted yet for this study

Summary

An Investigator initiated trial (IIT) using a prospective, randomized, double-blind, parallel group, placebo-controlled, clinical study design.

Conditions

Interventions

DRUG

Ambrisentan

Titration: Monotherapy using ambrisentan will be initialized at a beginning dose of 5 mg (once daily). Drug intake is scheduled at the morning. After 4 weeks monitoring, the dose of ambrisentan will be uptitrated to 10 mg once daily. Otherwise, if intolerability is indicated, a dose of 5 mg (once daily) will be maintained through the study duration. Maximum dose allowed: not to exceed 10 mg/day. Administration: Ambrisentan will be administered orally with or without food intake.

DRUG

Placebo

Placebo tablet (one to two tablets corresponding to one to two verum tablets). Administration: Placebo will be administrated orally with or without food intake in the morning.

Sponsors & Collaborators

  • Tianjin Medical University General Hospital

    collaborator OTHER

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Principal Investigators

  • Shao-Liang Chen, MD, PhD · Nanjing First Hospital, Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2025-12-30
Completion
2026-03-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04972656 on ClinicalTrials.gov