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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

Tracking Information
First Submitted Date  ICMJE December 8, 2009
First Posted Date  ICMJE December 9, 2009
Last Update Posted Date April 3, 2015
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2010)
Blood pressure [ Time Frame: Six months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
Blood pressure [ Time Frame: Nine months ]
Change History Complete list of historical versions of study NCT01028534 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
Oxygen desaturation index; Pulse rate; Endothelial dysfunction; Sleep quality and sleepiness; Health-related quality of life [ Time Frame: Nine months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)
Official Title  ICMJE Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Hypertension
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 8, 2009)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01028534
Other Study ID Numbers  ICMJE C359kyoto
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Toru Oga, Kyoto University, Graduate School of Medicine
Study Sponsor  ICMJE Kyoto University, Graduate School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kazuo Chin, MD, PhD Graduate School of Medicine, Kyoto University
Principal Investigator: Toru Oga, MD, PhD Graduate School of Medicine, Kyoto University
PRS Account Kyoto University, Graduate School of Medicine
Verification Date April 2015

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