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
|
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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 |
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 |

- prevention of high altitude pulmonary edema
- 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

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
Principal Investigator: | Marco Maggiorini, MD | University of Zurich |
Publications of Results:
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 Posted: | January 10, 2006 Key Record Dates |
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 |