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Main
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Note: This record shows only the 20 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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1 April 2013 |
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Main ID: |
NCT01028534 |
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Date of registration:
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08/12/2009 |
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Primary sponsor: |
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Public title:
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Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)
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Scientific title:
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Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea |
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Date of first enrolment:
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July 2010 |
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Target sample size:
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150 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01028534 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kazuo Chin, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Graduate School of Medicine, Kyoto University |
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Name:
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Toru Oga, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Graduate School of Medicine, Kyoto University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Apnea and hypopnea index of more than 20 /hr, and treated with CPAP
- Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg
or diastolic blood pressure of more than 80 mmHg
Exclusion Criteria:
- Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure
within 6 months
- Uncontrolled arrhythmia
- Severe hepatic or renal disorders
- Having poor prognosis disorders such as malignant disorders
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Obstructive Sleep Apnea
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Intervention(s)
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Drug: Olmesartan and Azelnidipine
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Primary Outcome(s)
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Blood pressure
[Time Frame: Six months]
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Secondary Outcome(s)
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Endothelial dysfunction
[Time Frame: Six months]
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Health-related quality of life
[Time Frame: Six months]
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Oxygen desaturation index
[Time Frame: Six months]
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Pulse rate
[Time Frame: Six months]
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Sleep quality and sleepiness
[Time Frame: Six months]
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Secondary ID(s)
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C359kyoto
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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