Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01060969
• Collaborator: (none)
• Enrollment: 55
• Locations: 3
• Arms: 2
• Duration (Months): 55
• Patients Per Site: 18.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Jan 1, 2006
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

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

Primary Outcome Measures

1. Results will be evaluated by using the Lake Louise AMS scoring system [one month after travel]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center of Geographic Medicine	Tel Hashomer		Israel
2	Sheba Medical Ctr.	Tel hashomer		Israel
3		Tel Hashomer		Israel

Sponsors and Collaborators

• Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Feb 2, 2010
• Last Update Posted: Sep 10, 2012
• Last Verified: Sep 1, 2012

• Keywords provided by Prof. Eli Schwartz MD, DTMH, Head of the Center for Travel and Geographic Medicine, 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: Pulmonary Edema; Altitude Sickness; Brain Edema; Edema; Acetazolamide; Tadalafil

Study Results

No Results Posted as of Sep 10, 2012