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Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)

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ClinicalTrials.gov Identifier: NCT01028534
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine

December 8, 2009
December 9, 2009
April 3, 2015
July 2010
December 2013   (Final data collection date for primary outcome measure)
Blood pressure [ Time Frame: Six months ]
Blood pressure [ Time Frame: Nine months ]
Complete list of historical versions of study NCT01028534 on ClinicalTrials.gov Archive Site
  • Oxygen desaturation index [ Time Frame: Six months ]
  • Pulse rate [ Time Frame: Six months ]
  • Endothelial dysfunction [ Time Frame: Six months ]
  • Sleep quality and sleepiness [ Time Frame: Six months ]
  • Health-related quality of life [ Time Frame: Six months ]
Oxygen desaturation index; Pulse rate; Endothelial dysfunction; Sleep quality and sleepiness; Health-related quality of life [ Time Frame: Nine months ]
Not Provided
Not Provided
 
Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)
Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea
The aim of the present study is to compare the effects of different types of antihypertensive drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients with hypertension and obstructive sleep apnea who are not controlled well with their hypertension after continuous positive airway pressure therapy.
Obstructive sleep apnea (OSA) and hypertension have a significant interrelationship, and both disorders are well known risk factors for cardiovascular diseases (CVD). Treating them appropriately may improve the prognosis of the patients. Presently, continuous positive airway pressure (CPAP) therapy is the first-line therapy for OSA, and angiotensin II receptor blockers and long-acting calcium channel blockers for hypertension in Japan. Therefore, in the present study, we wanted to compare the effects of these different types of antihypertensive drugs on the control of blood pressure in patients with OSA whose hypertension is not controlled well after CPAP therapy.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Obstructive Sleep Apnea
  • Hypertension
Drug: Olmesartan and Azelnidipine
  1. Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, increase Olmesartan to 40mg per day for the next 3 months
  2. Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 3 months
  3. Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 3 months
Other Names:
  • Olmesartan (angiotensin II receptor blockers: ARB)
  • Azelnidipine (long-acting calcium channel blockers: CCB)
  • Active Comparator: ARB plus increased ARB
    angiotensin II receptor blockers for the first 3 months and increasing dose of angiotensin II receptor blockers for the next 3 months
    Intervention: Drug: Olmesartan and Azelnidipine
  • Active Comparator: ARB plus CCB
    angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months
    Intervention: Drug: Olmesartan and Azelnidipine
  • Active Comparator: CCB plus ARB
    calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months
    Intervention: Drug: Olmesartan and Azelnidipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
Same as current
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01028534
C359kyoto
Yes
Not Provided
Not Provided
Toru Oga, Kyoto University, Graduate School of Medicine
Kyoto University, Graduate School of Medicine
Not Provided
Principal Investigator: Kazuo Chin, MD, PhD Graduate School of Medicine, Kyoto University
Principal Investigator: Toru Oga, MD, PhD Graduate School of Medicine, Kyoto University
Kyoto University, Graduate School of Medicine
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP