Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Prof. Eli Schwartz MD, DTMH, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT01060969

First received: November 3, 2008

Last updated: September 7, 2012

Last verified: September 2012

History of Changes

Purpose

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

Condition	Intervention
Pulmonary Edema Cerebral Edema	Drug: Tadalafil and acetazolamide Drug: Acetazolamide


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

Resource links provided by NLM:

MedlinePlus related topics: Edema Lead Poisoning

Drug Information available for: Acetazolamide Acetazolamide sodium Tadalafil

Genetic and Rare Diseases Information Center resources: Acute Mountain Sickness Pulmonary Edema of Mountaineers

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

Results will be evaluated by using the Lake Louise AMS scoring system [ Time Frame: one month after travel ] [ Designated as safety issue: Yes ]


Enrollment:	55
Study Start Date:	January 2006
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Acetazolamide acetazolamide 125 mg BID	Drug: Acetazolamide Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude
Experimental: Acetazolamide and Tadalafil Intervention arm	Drug: Tadalafil and acetazolamide Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

No agreement to sign informed consent.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060969

Locations


Israel

Tel Hashomer, Israel
Center of Geographic Medicine
Tel Hashomer, Israel
Sheba Medical Ctr.
Tel hashomer, Israel

Sponsors and Collaborators

Sheba Medical Center

More Information

Publications:

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.


Responsible Party:	Prof. Eli Schwartz MD, DTMH, Head of the Center for Travel and Geographic Medicine, Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT01060969 History of Changes
Other Study ID Numbers:	SHEBA-07-3977-ES-CTIL
Study First Received:	November 3, 2008
Last Updated:	September 7, 2012
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:


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

Additional relevant MeSH terms:


Altitude Sickness Lead Poisoning Pulmonary Edema Chemically-Induced Disorders Lung Diseases Poisoning Respiration Disorders Respiratory Tract Diseases Acetazolamide Tadalafil Anticonvulsants Carbonic Anhydrase Inhibitors Cardiovascular Agents	Central Nervous System Agents Diuretics Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Natriuretic Agents Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Physiological Effects of Drugs Therapeutic Uses Urological Agents Vasodilator Agents

ClinicalTrials.gov processed this record on March 03, 2015

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