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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
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
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
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
Brain Edema
Edema
Pulmonary Edema
Respiration Disorders
Respiratory Tract Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Lung Diseases
Acetazolamide
Tadalafil
Anticonvulsants
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013