Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00082186




Registration number
NCT00082186
Ethics application status
Date submitted
30/04/2004
Date registered
4/05/2004
Date last updated
12/02/2010

Titles & IDs
Public title
The Effect of Tracleer® on Male Fertility
Scientific 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
Secondary ID [1] 0 0
AC-052-402
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bosentan

Experimental: 1 - Oral bosentan tablets


Treatment: Drugs: bosentan
Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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%.
Timepoint [1] 0 0
From baseline to end of study.
Secondary outcome [1] 0 0
Semen volume, sperm motility and sperm morphology change
Timepoint [1] 0 0
From baseline to 3 & 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Brazil
State/province [6] 0 0
Sao Paulo
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Brno
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Prague
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrea Lauer, Ph.D.
Address 0 0
Actelion Pharmaceuticals US, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00082186