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Efficacy and Safety Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension

NCT05437224 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-06-29

No results posted yet for this study

Summary

This multicenter, open label, single-arm study is aim at investigating the the efficacy and safety of china made ambrisentan in Chinese subjects with PAH.

Conditions

Interventions

DRUG

Ambrisentan

eligible subjects received 5 mg ambrisentan orally once daily for a 12-week primary evaluation period. Subjects then proceeded to a 12-week dose adjustment period during which dose titration to 10 mg was allowed.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Shanghai Pulmonary Hospital, Shanghai, China

    collaborator OTHER

  • Xinqiao Hospital of Chongqing

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Wuhan Asia Heart Hospital

    collaborator OTHER

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jieyan Shen, PhD · Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2022-01-09
Completion
2022-02-06

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05437224 on ClinicalTrials.gov