Status:
COMPLETED
Effects of Nebivolol Versus Carvedilol on Cardiopulmonary Function at High Altitude in Healthy Subjects.
Lead Sponsor:
Istituto Auxologico Italiano
Collaborating Sponsors:
Menarini Group
Conditions:
Hypoxia
Altitude
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Exposure of healthy subjects to high altitude hypoxia elicits changes in cardiovascular, respiratory and metabolic features as weel as in exercise performance similar, for some aspects, to those obser...
Detailed Description
Methods. Study Subjects. Adults, males and females, non smoking healthy volunteers, sea-level residents not engaged in regular endurance exercise training, taking no medications will be recruited. As ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Men or women of any racial background
- healthy
- sealevel resident
- age \>= 18 years, =\< 65 years
- SBP\< 130 mmHg and DBP\< 80 mmHg, average of two measures at the sceening visit
- FG \< 100 mg/dl (5.6 mmol/l)
- BMI \< 25
- written informed consent signed
- Exclusion Criteria
- engagement in regular exercise training
- smoking habit
- being enrolled in another research study
- any current or previous cardiovascular, metabolic disease or any other cronic disease
- any current treatment for any medical condition
- any medical condition preventing or contraindication exposure to altitude hypoxia
- any gastrointestinal disorder interfering with drug absorption
- known allergy or contraindications to beta-blockers
- pregnant or lactating women; women in reproductive age not using recognized contraceptive methods.
- malignancy within the last 5 years
- drug abuse or alcohol abuse within the last 5 years
- history of noncompliance to medical regimens
- incapacity or unwillingness to sign the informed consent
- participation in any investigational clinical trial within the last 3 months
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00924833
Start Date
May 1 2006
End Date
November 1 2006
Last Update
September 2 2009
Active Locations (1)
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1
Laboratorio Ricerche Cardiologiche. Istituto Auxologico Italiano. Ospedale S. Luca. Via Spagnoletto, 3. Regina Margherita Hut (Monte Rosa, Italian Alps, 4559 m)
Milan, Italy, 20148