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Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention
This study has been completed.
Sponsor:
Sheba Medical Center
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
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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 Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Acute Mountain Sickness
Pulmonary Edema of Mountaineers
U.S. FDA Resources
Further study details as provided by Prof. Eli Schwartz MD, DTMH, Sheba Medical Center:
Primary Outcome Measures:
- Results will be evaluated by using the Lake Louise AMS scoring system [ Time Frame: one month after travel ]
| 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 (Adult, Senior) |
| 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 Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060969
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060969
Locations
| 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
Publications:
| 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 |
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 |
ClinicalTrials.gov processed this record on September 19, 2017