The Effect Of Tracleer™ On Male Fertility with Primary Pulmonary Arterial Hypertension (PPH) Currently Recruiting Patients For Study

The objective of the study is to evaluate the effects of chronic TRACLEER treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PPH).

Condition	Intervention	Phase
Hypertension, Pulmonary	Drug: Tracleer™ (bosentan)	Phase IV

Further Study Details: 

Expected Total Enrollment:  23

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• Male patients age 18-65 years.
• Bosentan-naďve.
• PPH, WHO functional class III/IV, in need of TRACLEER
• Patients pulmonary arterial hypertension (PAH) secondary to congenital heart disease.
• Written informed consent.

Exclusion Criteria:

• Female
• Patients with PAH secondary to connective tissue vascular diseases or HIV.
• Patients who have undergone a vasectomy.
• Patients with an average baseline sperm concentration < 15 x 10[6]/mL, or any sample with a sperm concentration <= 7.5 x 10[6]/mL.
• Patients with an average baseline sperm motility <20% or normal sperm morphology <5%.
• Body weight < 50 kg.
• Hypotension, defined as systolic blood pressure less than 85 mm Hg.
• AST and/or ALT plasma levels greater than 3 times ULN.
• Hypersensitivity to bosentan or any of the components of the formulation.
• Treatment with glyburide, cyclosporine A or tacrolimus at inclusion or planned during the study.
• Treatment with hormone suppressive agents, including androgens, estrogens, anabolic steroids or glucocorticoids within the past 6 months or planned during the study.
• Current treatment less than 3 months prior to inclusion or planned treatment with prostacyclin or prostacyclin analogues (e.g., Flolanâ or Remodulin).
• Patients who received an investigational drug in the month preceding the study start or who are due to be treated with another investigational drug during the study period.
• Known drug or alcohol dependence or any other factors that will interfere with conduct of the study.
• Any illness other than PPH that will reduce life expectancy to less than 6 months.
• Active cancer.
• Prior treatment with an anti-neoplastic agent or ionizing radiation.
• Hot tub/Jacuzzi use.
• Uncontrolled diseases including diabetes, liver or kidney disease.
• Patients receiving spironolactone (aldactone) less than 3 months prior to inclusion or dose >25 mg/day at baseline or anytime during the study.

Please refer to this study by ClinicalTrials.gov identifier  NCT00082186

Andrea Lauer, Ph.D.      650-624-6925    andrea.lauer@actelion.com
Mary Beth Turner, CTM      856-773-4306    mary-beth.turner@actelion.com

Alabama
      University of Alabama-Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
California
      University of California at San Diego, La Jolla,  California,  92037-1300,  United States; Recruiting
      Harbor - UCLA Medical Center, Torrance,  California,  90502,  United States; Recruiting
Colorado
      University of Colorado Health Sciences Center, Denver,  Colorado,  80262,  United States; Recruiting
New York
      New York Presbyterian Hospital, New York,  New York,  10032-3784,  United States; Recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting

Study chairs or principal investigators

Andrea Lauer, Ph.D.,  Study Director,  Actelion Pharmaceuticals US, Inc.   
Maurizio Rainisio, Ph.D.,  Study Director,  Actelion Pharmaceuticals, Ltd.   
Frederic Bodin, M.D.,  Study Director,  Actelion Pharmaceuticals, Ltd.   

Study ID Numbers:  AC-052-402
Last Updated:  November 7, 2005
Record first received:  April 30, 2004
ClinicalTrials.gov Identifier:  NCT00082186
Health Authority: United States: Food and Drug Administration