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

NCT00125918 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2008-02-21

No results posted yet for this study

Summary

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

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

tadalafil

tadalafil 2.5 mg and placebo tablets taken by mouth once a day for 16 weeks.

DRUG

tadalafil

tadalafil 10 mg and placebo tablets taken by mouth once a day for 16 weeks.

DRUG

tadalafil

tadalafil 20 mg and placebo tablets taken by mouth once a day for 16 weeks.

DRUG

tadalafil

tadalafil 40 mg and placebo tablets taken by mouth once a day for 16 weeks.

DRUG

placebo

placebo tablet taken by mouth once a day for 16 weeks

Sponsors & Collaborators

Principal Investigators

  • 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) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States
  • France
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00125918 on ClinicalTrials.gov