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Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

NCT ID: NCT01060969

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Edema Cerebral Edema

Keywords

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Acute Mountain Sickness travellers Acetazolamide Tadalafil Acute Mountain Sickness assessed by Lake Louise score High altitude pulmonary edema High altitude cerebral edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Acetazolamide

acetazolamide 125 mg BID

Group Type ACTIVE_COMPARATOR

Acetazolamide

Intervention Type DRUG

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

Acetazolamide and Tadalafil

Intervention arm

Group Type EXPERIMENTAL

Tadalafil and acetazolamide

Intervention Type DRUG

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

Interventions

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Tadalafil and acetazolamide

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

Intervention Type DRUG

Acetazolamide

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No agreement to sign informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Eli Schwartz MD, DTMH

Head of the Center for Travel and Geographic Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center of Geographic Medicine

Tel Litwinsky, , Israel

Site Status

Sheba Medical Ctr.

Tel Litwinsky, , Israel

Site Status

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

References

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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 2012 Jul 30.

Reference Type RESULT
PMID: 22943271 (View on PubMed)

Other Identifiers

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SHEBA-07-3977-ES-CTIL

Identifier Type: -

Identifier Source: org_study_id