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

February 13, 2008 updated by: Eli Lilly and Company

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

406

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • 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, France, 54511
        • 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.
  • Italy
      • Bergamo, Italy, 24128
        • 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.
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • 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.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • 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.
    • Utah
      • Salt Lake City, Utah, United States, 84143
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Drug: placebo
placebo tablet taken by mouth once a day for 16 weeks
Active Comparator: 2
2.5 mg tadalafil
Drug: tadalafil
tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 3
10 mg tadalafil
Drug: tadalafil
tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 4
20 mg tadalafil
Drug: tadalafil
tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Active Comparator: 5
40 mg tadalafil
Drug: tadalafil
tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351
Drug: tadalafil
tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.
Other Names:
  • LY450190
  • Cialis
  • IC351

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
6 minute walk distance change from baseline to Week 16
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
World Health Organization (WHO) functional class, Borg dyspnea, cardiopulmonary hemodynamics, quality of life - change from baseline to Week 16
Time Frame: 16 weeks
16 weeks
Time to first occurrence of clinical worsening
Time Frame: Not defined
Not defined

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

ICOS Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

August 1, 2005

First Submitted That Met QC Criteria

August 1, 2005

First Posted (Estimate)

August 2, 2005

Study Record Updates

Last Update Posted (Estimate)

February 21, 2008

Last Update Submitted That Met QC Criteria

February 13, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10303
  • H6D-MC-LVGY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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