NCT01702025|CompletedPhase 1/2Results
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Sponsor study identifier
interventional
41
1 country
1
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)In low oxygen environments, such as altitude, some adults may become ill and suffer from acute mountain sickness. Further, all adults will find that exercising becomes much more difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of this investigation is to study the effects of two drugs that may help people adjust to high-altitude quickly, prevent them from becoming ill and improve their exercise performance. The drugs are Methazolamide and Aminophylline.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 3, 2012
Actual (reported)October 5, 2012
Actual (reported)December 2012
Actual (reported)December 2012
Actual (reported)October 24, 2014
Actual (reported)Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).
After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.
The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia
Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions. Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions.
Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions. Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions.
Yellow corn meal in gel capsules
National Drug Code (NDC) 0143-1020-01
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Aminophylline+Methazolamide
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordColorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, 80523-1582, United States
Scalzo RL, Binns SE, Klochak AL, Giordano GR, Paris HL, Sevits KJ, Beals JW, Biela LM, Larson DG, Luckasen GJ, Irwin D, Schroeder T, Hamilton KL, Bell C. Methazolamide Plus Aminophylline Abrogates Hypoxia-Mediated Endurance Exercise Impairment. High Alt Med Biol. 2015 Dec;16(4):331-42. doi: 10.1089/ham.2015.0066.
Christopher Bell, PhD
Colorado State University
41 participants (actual enrollment reported by the registry).
First Submitted
October 3, 2012
First Posted
October 5, 2012
Study Start
June 2012
Date type not reportedThis date has not been verified as actual or estimated.
Study With Aminophylline to Attenuate of the Side Effects of Regadenoson
Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions. Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.
Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide) Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.
NDC 0781-1072-01
NDC 0143-1020-01 and NDC 0781-1072-01
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Primary Completion
December 2012
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
October 24, 2014
Results First Posted
October 24, 2014
Record last verified: 2014-10
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Source: ClinicalTrials.gov.
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