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PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension

PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension

NCT00125918•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and effectiveness of tadalafil for the treatment of pulmonary arterial hypertension.

Detailed Description

This is a randomized, double-blind, placebo-controlled, multicenter study. The key measure of effectiveness of the study drug will be determined using a 6-minute walk test. Eligible patients will be treated for 16 weeks and may be eligible to enter a 52-week extension phase study (PHIRST-2). Study procedures for both studies (PHIRST-1 and PHIRST-2) will include routine blood tests, medical history, physical exams, questionnaire responses, and exercise tests.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 12 years of age.
•Body weight at least 40 kg (approximately 88 pounds).
•Pulmonary hypertension (PAH) that is either idiopathic; related to collagen vascular disease; related to anorexigen use; associated with an atrial septal defect (resting SaO2 greater than or equal to 88%); with surgical repair, of at least 1 year duration, of a congenital systemic-to-pulmonary shunt.
•If on bosentan, must be at the maximal dose of 125 mg twice daily for a minimum of 12 weeks prior to screening and have an AST/ALT less than 3 times normal.
•History of PAH established by a resting mean pulmonary artery pressure greater than or equal to 25 mm Hg, pulmonary artery wedge pressure less than or equal to 15 mm Hg, and pulmonary vascular resistance greater than or equal to 3 Wood units via right heart catheterization
•Have World Health Organization functional class I, II, III or IV status.
•Have a qualifying 6-minute walk test distance at screening
•Have no evidence of significant parenchymal lung disease
•History of left-sided heart disease.
•History of atrial septostomy within 3 months before study entry
+3 more criteria

Exclusion Criteria

•Are nursing or pregnant.

Locations (6)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tucson, Arizona, United States

Minneapolis, Minnesota, United States

Salt Lake City, Utah, United States

Lille, France

Vandœuvre-lès-Nancy, France

Bergamo, Italy

Key Dates

Start Date

August 1, 2005

Primary Completion Date

August 1, 2007

Completion Date

August 1, 2007

Last Updated

February 21, 2008

Enrollment

406

ACTUAL participants

Conditions

Pulmonary Hypertension

Interventions

tadalafil

DRUG

tadalafil

DRUG

tadalafil

DRUG

tadalafil

DRUG

placebo

DRUG

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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Pulmonary Hypertension

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 21, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Preliminary Human Trials of F230 Tablets

Sildinafil in Pulmonary Hypertension-Rheumatic Chronic Valvular Disease(RCT)

Prospective Evaluation of AI-ECG for SHD Detection

Pulmonary Hypertension in Left Heart Disease

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH