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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: tadalafil (Drug); tadalafil (Drug); tadalafil (Drug); tadalafil (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 6 minute walk distance change from baseline to Week 16

Secondary outcome:

World Health Organization (WHO) functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - change from baseline to Week 16

Time to first occurrence of clinical worsening

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

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Exclusion Criteria:

- Are nursing or pregnant.

- PAH due to conditions other than noted in the above inclusion criteria.

- History of left-sided heart disease.

- History of atrial septostomy within 3 months before study entry

- History of angina pectoris or other condition that was treated with long-or

short-acting nitrates within 12 weeks before administration of study drug.

- History of symptomatic coronary disease.

- Have any therapy with a prostacyclin or analogue, L-arginine, phosphodiesterase (PDE)

inhibitor, or investigational drug within 4 weeks before administration of study drug.

Locations and Contacts

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., Lille 59037, France

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., Vandoeuvre Les Nancy 54511, France

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., Bergamo 24128, Italy

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 85724, United States

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., Minneapolis, Minnesota 55455, United States

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., Salt Lake City, Utah 84143, United States

Additional Information

The Pulmonary Hypertension Association (PHA) is an organization that provides support, education, advocacy, and awareness about pulmonary hypertension.

Lilly Clinical Trial Registry

Starting date: August 2005
Last updated: February 13, 2008

Page last updated: August 23, 2015

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