Tracleer and PPH News
The Effect Of Tracleer·On Male Fertility with Primary Pulmonary Arterial Hypertension (PPH) Currently Recruiting Patients For Study
By Clinicals Trials - U.S. National Library of Medicine
November 19, 2005
The Effect of Tracleer·on Male Fertility
This study is currently recruiting patients.
Verified by Actelion August 2005
Sponsored by: Actelion
Information provided by: Actelion
ClinicalTrials.gov Identifier: NCT00082186
Purpose
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
Hypertension, Pulmonary
Intervention
Drug: Tracleer·(bosentan)
Phase
Phase IV
MedlinePlus related topics: Pulmonary Hypertension
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Factorial Assignment, Safety Study
Official Title: TRACLEER·(Bosentan) Pulmonary Arterial Hypertension A Multicenter, Open-Label, Single-Arm Safety Study to Investigate the Effects of Chronic TRACLEER·Treatment on Testicular Function in Male Patients With Pulmonary Arterial Hypertension
Further Study Details:
Expected Total Enrollment: 23
Study start: October 2002
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Male
Criteria
Inclusion Criteria:
-Male patients age 18-65 years.
-Bosentan-na·e.
-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., Flolan·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.
Location and Contact Information
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
Kevin Land 205-934-8767 chfnurse@cardio.dom.uab.edu
Andrea Lauer, Ph.D. 650-624-6925 andrea.lauer@actelion.com
Raymond L Benza, MD, Principal Investigator
Robert Bourge, MD, Sub-Investigator
California
University of California at San Diego, La Jolla, California, 92037-1300, United States; Recruiting
Katie Kinninger 858-657-7122 kkinninger@ucsd.edu
Andrea Lauer, Ph.D. 650-624-6925 andrea.lauer@actelion.com
Nick Kim, MD, Principal Investigator
Harbor - UCLA Medical Center, Torrance, California, 90502, United States; Recruiting
Joy Beckmann 310-222-3560 jbeckmann@rei.edu
Andrea Lauer, Ph.D. 650-624-6925 andrea.lauer@actelion.com
Ronald Oudiz, MD, Principal Investigator
Colorado
University of Colorado Health Sciences Center, Denver, Colorado, 80262, United States; Recruiting
Debbie McCollister 303-315-1801 deb.mccollister@uchsc.edu
Andrea Lauer, Ph.D. 650-624-6925 andrea.lauer@actelion.com
David Badesch, MD, Principal Investigator
New York
New York Presbyterian Hospital, New York, New York, 10032-3784, United States; Recruiting
Daniella Brady 212-305-4321 dm2069@columbia.edu
Andrea Lauer, Ph.D. 650-624-6925 andrea.lauer@actelion.com
Robyn Barst, MD, Principal Investigator
Texas
Baylor College of Medicine, Houston, Texas, 77030, United States; Recruiting
Helena Purl 713-790-2076 hpurl@bcm.tmc.edu
Andrea Lauer, Ph.D. 650-624-6925 andrea.lauer@actelion.com
Adaani Frost, MD, Principal Investigator
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.
More Information
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
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