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Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01060969
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Eli Schwartz MD, DTMH, Sheba Medical Center

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

Condition or disease Intervention/treatment Phase
Pulmonary Edema Cerebral Edema Drug: Tadalafil and acetazolamide Drug: Acetazolamide Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
Study Start Date : January 2006
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Results will be evaluated by using the Lake Louise AMS scoring system [ Time Frame: one month after travel ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060969


Locations
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Israel
Center of Geographic Medicine
Tel Hashomer, Israel
Sheba Medical Ctr.
Tel hashomer, Israel
Tel Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
More Information
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Publications of Results:

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Responsible Party: Prof. Eli Schwartz MD, DTMH, Head of the Center for Travel and Geographic Medicine, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01060969    
Other Study ID Numbers: SHEBA-07-3977-ES-CTIL
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: September 2012
Keywords provided by Prof. Eli Schwartz MD, DTMH, 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:
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Pulmonary Edema
Altitude Sickness
Brain Edema
Edema
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetazolamide
Tadalafil
 Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anticonvulsants
Carbonic Anhydrase Inhibitors
Diuretics
Natriuretic Agents
Physiological Effects of Drugs