Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

Not Applicable

Completed

• Conditions: Pulmonary Edema; Cerebral Edema
• Interventions: Drug: Acetazolamide; Drug: Tadalafil and acetazolamide

• Registration Number: NCT01060969
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-11-03
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-07
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Participant in trekking to high altitude
• Agreement to sign the informed consent.

Exclusion Criteria

• No agreement to sign informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetazolamide	Acetazolamide	acetazolamide 125 mg BID
Acetazolamide and Tadalafil	Tadalafil and acetazolamide	Intervention arm

Primary Outcome Measures

Name	Time	Method
Results will be evaluated by using the Lake Louise AMS scoring system	one month after travel

Trial Locations

Locations (2)

Center of Geographic Medicine; 🇮🇱 Tel Hashomer, Israel

Sheba Medical Ctr.; 🇮🇱 Tel hashomer, Israel