CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
placebo +2 moredrug
Likely dose
Carvedilol 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00924833
NCT00924833Phase 4Completed

Comparison of the Cardiovascular, Metabolic and Respiratory Effects of Nebivolol and Carvedilol at High Altitude in Healthy Subjects.

Istituto Auxologico Italiano·interventional·Posted Jun 19, 2009·Updated Sep 2, 2009

In Brief

A Phase 4 clinical trial evaluating placebo, Carvedilol, and 1 other intervention for Hypoxia and 2 related conditions. Completed, enrolled 27 participants across 1 site.

Detailed 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 observed in chronic heart failure. Exposure to high altitude hypoxia represents a suitable model to assess different treatments proposed for this pathological condition. Our aim was to evaluate the impact of two different third-generation beta-blockers used in heart failure (carvedilol and nebivolol) on cardiovascular, respiratory, metabolic profile and on exercise performance at high altitude.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
CollaboratorsMenarini Group

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 19, 2009
Enrollment StartMay 1, 2006
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.0 years ago

Interventions

placebodrug

placebo tablet BID

Carvediloldrug

Carvedilol 25 mg tablets. One tablet twice daily.

Nebivololdrug

nebivolol 5 mg tablets. One nebivolol tablet daily. One placebo tablet daily.