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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01028534
First received: December 8, 2009
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Obstructive Sleep Apnea
Hypertension
 Drug: Olmesartan and Azelnidipine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oxygen desaturation index [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Pulse rate [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Endothelial dysfunction [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Sleep quality and sleepiness [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 8, 2009
Last Updated: March 25, 2013
Health Authority: Japan: Institutional Review Board

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

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
 Angiotensin II
Olmesartan medoxomil
Antihypertensive Agents
Calcium Channel Blockers
Olmesartan
Angiotensin Receptor Antagonists
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on May 16, 2013