Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

Sheba Medical Center55 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pulmonary Edema Cerebral Edema

Interventions

Tadalafil and acetazolamideDRUG

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

AcetazolamideDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Participant in trekking to high altitude * Agreement to sign the informed consent. Exclusion Criteria: * No agreement to sign informed consent.

Locations (3)

Center of Geographic Medicine

Tel Litwinsky, Israel

Sheba Medical Ctr.

Tel Litwinsky, Israel

Unnamed facility

Tel Litwinsky, Israel

Outcomes

Primary Outcomes

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

Time frame: one month after travel

Data from ClinicalTrials.gov

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