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

Hypertension Clinical Trial

Official title:

Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028534
• Other study ID #: C359kyoto
• Status: Completed
• Phase: N/A
• First received: December 8, 2009
• Last updated: April 1, 2015
• Start date: July 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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 3 months Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 3 months Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 3 months

Locations

Country	Name	City	State
Japan	Kirigaoka Tsuda Hospital	Kitakyushu
Japan	Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		Six months	No
Secondary	Oxygen desaturation index		Six months	No
Secondary	Pulse rate		Six months	No
Secondary	Endothelial dysfunction		Six months	No
Secondary	Sleep quality and sleepiness		Six months	No
Secondary	Health-related quality of life		Six months	No