Back to resultsTadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
Primary Purpose
Pulmonary Edema, Cerebral Edema
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tadalafil and acetazolamide
Acetazolamide
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Edema focused on measuring Acute Mountain Sickness, travellers, Acetazolamide, Tadalafil, Acute Mountain Sickness assessed by Lake Louise score, High altitude pulmonary edema, High altitude cerebral edema
Eligibility Criteria
Inclusion Criteria:
- Participant in trekking to high altitude
- Agreement to sign the informed consent.
Exclusion Criteria:
- No agreement to sign informed consent.
Sites / Locations
- Center of Geographic Medicine
- Sheba Medical Ctr.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Acetazolamide
Acetazolamide and Tadalafil
Arm Description
acetazolamide 125 mg BID
Intervention arm
Outcomes
Primary Outcome Measures
Results will be evaluated by using the Lake Louise AMS scoring system
Secondary Outcome Measures
Full Information
NCT ID
NCT01060969
First Posted
November 3, 2008
Last Updated
September 7, 2012
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01060969
Brief Title
Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
Official Title
Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
A randomized controlled study comparing:
Tadalafil [20mg x1/day] and acetazolamide [125mg x2 day], versus Acetazolamide [125mg x2 day] alone, in trekkers to altitude > 3,000 m.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Edema, Cerebral Edema
Keywords
Acute Mountain Sickness, travellers, Acetazolamide, Tadalafil, Acute Mountain Sickness assessed by Lake Louise score, High altitude pulmonary edema, High altitude cerebral edema
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetazolamide
Arm Type
Active Comparator
Arm Description
acetazolamide 125 mg BID
Arm Title
Acetazolamide and Tadalafil
Arm Type
Experimental
Arm Description
Intervention arm
Intervention Type
Drug
Intervention Name(s)
Tadalafil and acetazolamide
Intervention Description
Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Intervention Description
Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude
Primary Outcome Measure Information:
Title
Results will be evaluated by using the Lake Louise AMS scoring system
Time Frame
one month after travel
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant in trekking to high altitude
Agreement to sign the informed consent.
Exclusion Criteria:
No agreement to sign informed consent.
Facility Information:
Facility Name
Center of Geographic Medicine
City
Tel Hashomer
Country
Israel
Facility Name
Sheba Medical Ctr.
City
Tel hashomer
Country
Israel
City
Tel Hashomer
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
22943271
Citation
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.
Results Reference
result
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Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
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