Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
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ClinicalTrials.gov Identifier: NCT01060969 |
Recruitment Status
:
Completed
First Posted
: February 2, 2010
Last Update Posted
: September 10, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Edema Cerebral Edema | Drug: Tadalafil and acetazolamide Drug: Acetazolamide | Not Applicable |
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 (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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Participant in trekking to high altitude
- Agreement to sign the informed consent.
Exclusion Criteria:
- No agreement to sign informed consent.

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
Israel | |
Center of Geographic Medicine | |
Tel Hashomer, Israel | |
Sheba Medical Ctr. | |
Tel hashomer, Israel | |
Tel Hashomer, Israel |
Publications of Results:
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 |
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:
Edema Pulmonary Edema Altitude Sickness Brain Edema Signs and Symptoms Lung Diseases Respiratory Tract Diseases Respiration Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Tadalafil |
Acetazolamide 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 |