Hypertension, Pulmonary
Conditions
Brief summary
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 (PAH).
Interventions
DRUGbosentan
Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
Sponsors
Actelion
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male patients age 18-65 years. * Bosentan-naïve. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a mean decrease in sperm concentration to 7.5 x 10[6]/mL or below, without a single sperm concentration ≥ 20 x 10[6]/mL, at 3 or 6 months. This proportion is considered of clinical relevance if greater than 30%. | From baseline to end of study. |
Secondary
| Measure | Time frame |
|---|---|
| Semen volume, sperm motility and sperm morphology change | From baseline to 3 & 6 months |
Outcome results
None listed