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Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension

NCT04483115 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-24

No results posted yet for this study

Summary

This study is a phase IIa proof-of-concept study to evaluate the effect of single-dose TPN171H tablets on acute haemodynamic parameters in patients with pulmonary arterial hypertension.The trial is expected to include 60 patients, divided into 6 groups, according to 1:1:1:1:1:1 into the placebo group and the test drugs 2.5mg, 5mg, 10mg group, tadalafil tablets 20mg, 40mg group, each group 10 cases.

Conditions

Interventions

DRUG

TPN171H

Tablets; Oral; Single dose

DRUG

Placebo

Tablets; Oral; Single dose

DRUG

Tadalafil

Tablets; Oral; Single dose

Sponsors & Collaborators

  • Shanghai Institute of Materia Medica, Chinese Academy of Sciences

    collaborator OTHER

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • Yong Huo · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2022-06-29
Completion
2022-06-29

Countries

  • China

Study Locations

More Related Trials

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 NCT04483115 on ClinicalTrials.gov