- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01352065
Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration (ERAATH)
May 7, 2013 updated by: Center for Health, Exercise and Sport Sciences, Serbia
Phase 3 Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration
Endothelin receptors antagonists (ERA), such as bosentan and ambrisentan, are a class of vasoactive drugs that have been developed for the treatment of pulmonary arterial hypertension.
It has been anecdotally reported that ERA is frequently used among top-level athletes to counteract exercise-induced rise in pulmonary vascular pressures and increase exercise performance.
Yet, the effects of ERA on exercise capacity in healthy humans are puzzling, with the drugs not included in the current Prohibited List, since the ergogenic potential is yet to be fully understood and determined.
Furthermore, the urinary excretion of ERA metabolites following administration has not been studied systematically at rest and during exercise in athletes, as a way to detect its intake if performance-enhancing potential is confirmed.
In the planned study ERA will be administered in newly approved doses for 8 weeks in order to assess the presumed doping potential for both male and female athletes, and to monitor serum and urinary ERA excretion dynamics after single- and multiple-dose administration.
The possible effects of prolonged ERA administration in higher doses on exercise performance may be relevant, if further confirmed, in terms of their possible fraudulent utilization to influence exercise performance in sports, raising the difficult question of whether, particularly in some circumstances, the ERA might be considered as prohibited substances in athletes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Preliminary findings of our research group indicated that ERA enhances exercise performance (particularly aerobic) after 7-day intake of higher doses of non-selective ERA bosentan (doses used were approved for pulmonary arterial hypertension treatment).
This is in part in accordance with results of previous research (Faoro et al. 2009), although authors administered regular single dose (62.5 mg) of bosentan in hypoxic healthy subjects.
Our study should examine metabolic profiles of athletes after receiving significantly higher doses of two oral ERA as compared to previous research, along with assessment of ergogenic potential with 8 weeks of administration in placebo-control and randomized design.
We expect that ERA will increase time to exhaustion during endurance test, increase the maximal oxygen uptake and rate of ultra-short term heart rate recovery after exercise, and affecting blood and urine cortisol, testosterone and dehydroepiandrosterone following administration.
Moreover, we will clearly evaluate 24-h pharmacokinetic profile of ERA in blood and urine and collect data for concentration-time profiles of ERA and main active metabolites, in aim to provide more rationale basis for identification and detection for doping control.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Belgrade, Serbia, 11000
- Center for Health, Exercise and Sport Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- male and female volunteers
- experienced in athletic training (> 5 years of experience)
- aged 20 to 30 years
- free from musculoskeletal dysfunctions
- free from metabolic and heart diseases
Exclusion Criteria:
- pregnancy
- use of hormonal contraceptives
- use of dietary supplement that contains any ergogenic agent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: PLACEBO
|
Tablet, 10 mg per day, single per day, 8 weeks
|
EXPERIMENTAL: BOSENTAN
|
tablet, 250 mg per day, twice per day, 8 weeks
|
EXPERIMENTAL: AMBRISENTAN
|
tablet, 10 mg per day, single per day, 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal oxygen uptake
Time Frame: Change from Baseline in Maximal oxygen uptake at 8 weeks
|
Maximal oxygen uptake is the maximum capacity of an individual's body to transport and use oxygen during incremental exercise, which reflects the physical fitness of the individual.
|
Change from Baseline in Maximal oxygen uptake at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentration of bosentan
Time Frame: Regular sampling will be performed during administration at 0, 1, 2, 4, 6, and 8 weeks, and after 2 and 4 weeks post-administration
|
Regular sampling will be performed during administration at 0, 1, 2, 4, 6, and 8 weeks, and after 2 and 4 weeks post-administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Sergej M Ostojic, MD, PhD, Center for Health, Exercise and Sport Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
May 9, 2011
First Submitted That Met QC Criteria
May 10, 2011
First Posted (ESTIMATE)
May 11, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
May 8, 2013
Last Update Submitted That Met QC Criteria
May 7, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHS-ERA-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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