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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

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Hypertension Drug: Olmesartan and Azelnidipine Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea
Study Start Date : July 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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 CCB
angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months
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: CCB plus ARB
calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months
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)




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Oxygen desaturation index [ Time Frame: Six months ]
  2. Pulse rate [ Time Frame: Six months ]
  3. Endothelial dysfunction [ Time Frame: Six months ]
  4. Sleep quality and sleepiness [ Time Frame: Six months ]
  5. Health-related quality of life [ Time Frame: Six months ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028534


Locations
Japan
Kirigaoka Tsuda Hospital
Kitakyushu, Japan
Kyoto University Hospital
Kyoto, Japan
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Investigators
Principal Investigator: Kazuo Chin, MD, PhD Graduate School of Medicine, Kyoto University
Principal Investigator: Toru Oga, MD, PhD Graduate School of Medicine, Kyoto University

Responsible Party: Toru Oga, Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01028534     History of Changes
Other Study ID Numbers: C359kyoto
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Toru Oga, Kyoto University, Graduate School of Medicine:
Continuous positive pressure ventilation
Blood pressure
Oxygen desaturation index
Endothelial dysfunction
Patient reported measurement

Additional relevant MeSH terms:
Hypertension
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Calcium, Dietary
Olmesartan
Antihypertensive Agents
Olmesartan Medoxomil
Angiotensin Receptor Antagonists
Angiotensin II
Angiotensinogen
Calcium Channel Blockers
Bone Density Conservation Agents
Physiological Effects of Drugs
Angiotensin II Type 1 Receptor Blockers
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors