Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

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

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Key information

Conditions

Pulmonary Edema Altitude Sickness Brain Diseases Brain Edema Central Nervous System Diseases Cerebral Edema Lung Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Geographic Medicine, Tel Litwinsky, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

No agreement to sign informed consent.

Treatment and study plan

Tadalafil and acetazolamide

Drug

Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.

Acetazolamide

Drug

Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude

Primary outcomes

Results will be evaluated by using the Lake Louise AMS scoring system

Time frame: one month after travel

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Feb 2, 2010
Registry last updated: Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed