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Prevention of High Altitude Pulmonary Edema

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ClinicalTrials.gov Identifier: NCT00274430
Recruitment Status : Completed
First Posted : January 10, 2006
Last Update Posted : December 4, 2006
Information provided by:
University of Zurich

Brief Summary:

A double-blind placebo controlled study

  • To compare the effect of tadalafil and dexamethasone versus placebo on Ppa and pulmonary edema formation in subjects susceptible to HAPE.
  • To investigate the effect of dexamethasone on alveolar fluid clearance, as assessed by measurement of the nasal potential difference, and prevention of HAPE.
  • To investigate the effect of the tadalafil and dexamethasone versus placebo on the dynamic CBF autoregulation properties and on the development of AMS in HAPE susceptible subjects.

Condition or disease Intervention/treatment Phase
High Altitude Pulmonary Edema Drug: dexamethasone 8 mg bid Drug: tadalafil 10mg bid Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of the Effects of Tadalafil and Dexamethasone Versus Placebo on Pulmonary Edema Formation and Cerebral Blood Flow Autoregulation in High Altitude Newcomers With a Previous History of High Altitude Pulmonary Edema
Study Start Date : July 2003
Study Completion Date : September 2003

Primary Outcome Measures :
  1. prevention of high altitude pulmonary edema

Secondary Outcome Measures :
  1. incidence of acute mountain sickness

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • At least one previous episode of high altitude pulmonary edema

Exclusion Criteria:

  • pulmonary arterial hypertension
  • congenital heart disease
  • any chronic lung disease

Information from the National Library of Medicine

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): NCT00274430

Sponsors and Collaborators
University of Zurich
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Principal Investigator: Marco Maggiorini, MD University of Zurich
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00274430    
Other Study ID Numbers: margherita03
First Posted: January 10, 2006    Key Record Dates
Last Update Posted: December 4, 2006
Last Verified: December 2003
Additional relevant MeSH terms:
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Altitude Sickness
Pulmonary Edema
Hypertension, Pulmonary
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents