Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
1 other identifier
interventional
55
1 country
3
Brief Summary
To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in preventing acute mountain sickness in travelers to high altitude areas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2006
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 10, 2012
September 1, 2012
4.6 years
November 3, 2008
September 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Results will be evaluated by using the Lake Louise AMS scoring system
one month after travel
Study Arms (2)
Acetazolamide
ACTIVE COMPARATORacetazolamide 125 mg BID
Acetazolamide and Tadalafil
EXPERIMENTALIntervention arm
Interventions
Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.
Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude
Eligibility Criteria
You may qualify if:
- Participant in trekking to high altitude
- Agreement to sign the informed consent.
You may not qualify if:
- No agreement to sign informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Center of Geographic Medicine
Tel Litwinsky, Israel
Sheba Medical Ctr.
Tel Litwinsky, Israel
Unknown Facility
Tel Litwinsky, Israel
Related Publications (1)
Leshem E, Caine Y, Rosenberg E, Maaravi Y, Hermesh H, Schwartz E. Tadalafil and acetazolamide versus acetazolamide for the prevention of severe high-altitude illness. J Travel Med. 2012 Sep-Oct;19(5):308-10. doi: 10.1111/j.1708-8305.2012.00636.x. Epub 2012 Jul 30.
PMID: 22943271RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Center for Travel and Geographic Medicine
Study Record Dates
First Submitted
November 3, 2008
First Posted
February 2, 2010
Study Start
January 1, 2006
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
September 10, 2012
Record last verified: 2012-09