Tadalafil and Acetazolamide Versus Acetazolamide in Acute Mountain Sickness Prevention

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01060969

Enrollment

Registered

2010-02-02

Start date

2006-01-31

Completion date

2010-08-31

Last updated

2012-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Edema, Pulmonary Edema

Keywords

Acute Mountain Sickness, travellers, Acetazolamide, Tadalafil, Acute Mountain Sickness assessed by Lake Louise score, High altitude pulmonary edema, High altitude cerebral edema

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.

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.

Interventions

DRUGTadalafil and acetazolamide

Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude.

DRUGAcetazolamide

Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Results will be evaluated by using the Lake Louise AMS scoring system	one month after travel

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026