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Prevention of High Altitude Pulmonary Edema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00274430
First Posted: January 10, 2006
Last Update Posted: December 4, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Zurich
  Purpose

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 Intervention Phase
High Altitude Pulmonary Edema Drug: dexamethasone 8 mg bid Drug: tadalafil 10mg bid Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • prevention of high altitude pulmonary edema

Secondary Outcome Measures:
  • incidence of acute mountain sickness

Estimated Enrollment: 30
Study Start Date: July 2003
Estimated Study Completion Date: September 2003
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • At least one previous episode of high altitude pulmonary edema

Exclusion Criteria:

  • pulmonary arterial hypertension
  • congenital heart disease
  • any chronic lung disease
  Contacts and Locations
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
Investigators
Principal Investigator: Marco Maggiorini, MD University of Zurich
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00274430     History of Changes
Other Study ID Numbers: margherita03
First Submitted: January 9, 2006
First Posted: January 10, 2006
Last Update Posted: December 4, 2006
Last Verified: December 2003

Additional relevant MeSH terms:
Edema
Altitude Sickness
Pulmonary Edema
Hypertension, Pulmonary
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Tadalafil
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents