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NCT01060969 Clinical Trial

Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

Pulmonary Edema Clinical Trial

Official title:
Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01060969
Other study ID # SHEBA-07-3977-ES-CTIL
Secondary ID
Status Completed
Phase N/A
First received November 3, 2008
Last updated September 7, 2012
Start date January 2006
Est. completion date August 2010

Study information
Verified date September 2012
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in preventing acute mountain sickness in travelers to high altitude areas.

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.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participant in trekking to high altitude

- Agreement to sign the informed consent.

Exclusion Criteria:

- No agreement to sign informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Tadalafil and acetazolamide
Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.
• Acetazolamide
Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude

Locations
Country Name City State
Israel Center of Geographic Medicine Tel Hashomer
Israel Sheba Medical Ctr. Tel hashomer

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & 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 201 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Results will be evaluated by using the Lake Louise AMS scoring system one month after travel Yes
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