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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 October 2021 |
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Main ID: |
NCT03536455 |
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Date of registration:
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14/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude
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Scientific title:
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Effect of Acetazolamide on Maximal Exercise Performance in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial |
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Date of first enrolment:
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May 15, 2018 |
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Target sample size:
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92 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03536455 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Kyrgyzstan
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Contacts
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Name:
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Michael Furian, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Zürich |
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Name:
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Konrad E Bloch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Zürich |
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Name:
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Talant M Sooronbaev, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy men and women, age 40-75 yrs, without any disease and need of medication.
- Born, raised and currently living at low altitude (<800m).
- Written informed consent.
- Kyrgyz ethnicity
Exclusion Criteria:
- Any active respiratory, cardiovascular or other disease requiring regular treatment or
being otherwise relevant for tolerance of hypoxia or altitude exposure.
- Any condition that may interfere with protocol compliance including current heavy
smoking (>20 cigarettes per day or >20 pack-years with active smoking during the last
10 years), regular use of alcohol.
- Allergy to acetazolamide and other sulfonamides.
Age minimum:
40 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Altitude Hypoxia
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Intervention(s)
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Drug: ACETAZOLAMIDE oral capsule
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Drug: Placebo oral capsule
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Primary Outcome(s)
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Change in maximal power output during exercise
[Time Frame: Day 1 at 760m and day 1 at 3'100m]
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Secondary Outcome(s)
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Change in cerebral tissue oxygenation during exercise
[Time Frame: Day 1 at 760m and day 1 at 3'100m]
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Change in arterial blood gasses at rest and peak exercise
[Time Frame: Day 1 at 760m and day 1 at 3'100m]
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Change in peak oxygen uptake during exercise
[Time Frame: Day 1 at 760m and day 1 at 3'100m]
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Change in muscle tissue oxygenation during exercise
[Time Frame: Day 1 at 760m and day 1 at 3'100m]
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Secondary ID(s)
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2018-01-8/305B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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