An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 350

Inclusion Criteria

- For purposes of study entry, clinical worsening is defined as WHO functional class deterioration and documentation of clinical worsening. The following subjects will be eligible to enter the extension trial.
• The subject discontinues the placebo-controlled study (LVGY) due to clinical worsening and is on placebo, tadalafil 2.5 mg, 10 mg, or 20 mg.
• The 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 placebo, tadalafil 2.5
mg, 10 mg, or 20 mg.
- A female subject of childbearing potential must have a negative urine pregnancy test at the screening visit and agree to use two medically reliable methods of contraception (e.g., barrier with spermacide or hormonal contraception) until study completion.
- Written informed consent (and written assent for minors) will be obtained prior to any study procedure being performed.

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

- Are nursing or pregnant.
- Have left-sided heart disease, including any of the following:
clinically significant aortic or mitral valve disease (i.e., aortic stenosis, aortic insufficiency, mitral stenosis, moderate or greater mitral regurgitation); pericardial constriction; restrictive or congestive cardiomyopathy; left ventricular ejection fraction < 40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography; left ventricular shortening fraction < 22% by echocardiography; life-threatening cardiac arrhythmias; symptomatic coronary artery disease within 5 years of study entry.
- Have a systolic blood pressure < 90 mm Hg or diastolic blood pressure < 50 mm Hg at screening.
- Have a history of angina pectoris or other condition that was treated with long-or short-acting nitrates within 12 weeks before administration of study drug.
- Have a musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease besides pulmonary arterial hypertension that may significantly limit ambulation.
- Current treatment with antiretroviral therapy (protease inhibitor), sustemic ketoconazole, or systemic itraconazole.
- Current treatment with a prostacyclin or analogue, L-arginine, phosphodiesterase inhibitor other than tadalafil, or investigational drug. An exception is allowed in Japan for subjects who participated in placebo-controlled study LVGY while receiving treatment with beraprost sodium.
- Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Are employed by Lilly or ICOS (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or ICOS employees may participate in Lilly ICOS LLC-sponsored clinical trials, but are not permitted to participate at a Lilly or ICOS facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials