Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

Sheba Medical Center

Status: Completed

Conditions: Cerebral Edema; Pulmonary Edema

Treatments: Drug: Acetazolamide; Drug: Tadalafil and acetazolamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01060969

SHEBA-07-3977-ES-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• No agreement to sign informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Acetazolamide

Active Comparator group

Description:

acetazolamide 125 mg BID

Treatment:

Drug: Acetazolamide

Acetazolamide and Tadalafil

Experimental group

Description:

Intervention arm

Treatment:

Drug: Tadalafil and acetazolamide