A double blind, Extension Study to evaluate the Long-term safety and Efficacy of the phsphodiesterase Type 5 (PDE5) inhibitor Tadalafil in the Treatment of patients with Pulmonary Arterial Hypertension.

Conditions: Pulmonary Arterial Hypertension
MedDRA version: 14.1Level: LLTClassification code 10037405Term: Pulmonary hypertension primarySystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2005-002844-24-IT

Lead Sponsor: ELI LILLY

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

Subject discontinues the placebo-controlled study (LVGY) due to clinical worsening and is on placebo, tadalafil 2.5mg, 10 mg or 20 mg.
Subject completes week 16 in the placebo-controlled study (LVGY) and has one of the following:
-no clinical worsening
-clinical worsening at the Week 16 Visit and is receiving plcebo, tadalafil 2.5 mg, 10 mg or 20 mg.
Female subject with a negative urine pregnancy test at screening Visit
Written informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-nursing or pregnant
-have left sided heart disease
-have a systolic blood pressure < 90mm Hg or diastolic blood pressure <50 mm Hg
-have history of Angina pectoris
-have musculoskeletal disorder
-have a history of symptomatic coronary disease
-Have a history of HIV infection
-current treatment with antiretroviral therapy
-current treatment with prostacyclin or analogue
-investigator site personnel directly affiliated with the study
-employed by Lilly or ICOS.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the long term safety and efficacy of tadalafil 20 mg and 40 mg once daily in the treatment of patients with PAH;Secondary Objective: to determine the durability of efficacy;Primary end point(s): to evaluate the long term safety and efficacy of tadalafil 20 mg and 40 mg once daily in the treatment of patients with PAH

Secondary Outcome Measures