Official Title: “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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: March 2014

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.

Intervention(s) in this Clinical Trial

• Drug: Olmesartan and Azelnidipine
  • Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, increase Olmesartan to 40mg per day for the next 6 months Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 6 months Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 6 months

Arms, Groups and Cohorts in this Clinical Trial

• 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 6 months
• Active Comparator: ARB plus CCB
  • angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 6 months
• Active Comparator: CCB plus ARB
  • calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 6 months

Primary Measures

• Blood pressure
  • Time Frame: Nine months
    Safety Issue?: No

Secondary Measures

• Oxygen desaturation index; Pulse rate; Endothelial dysfunction; Sleep quality and sleepiness; Health-related quality of life
  • Time Frame: Nine months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kyoto University, Graduate School of Medicine

Overall Clinical Trial Officials and Contacts

Kazuo Chin, MD, PhD Principal Investigator Graduate School of Medicine, Kyoto University  

Overall Contact: Toru Oga, MD, PhD +81-75-751-3852 ogato@kuhp.kyoto-u.ac.jp

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01028534

Study ID Number: C359kyoto

ClinicalTrials.gov Identifier: NCT01028534

Health Authority: Japan: Institutional Review Board