NCT01028534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

3.4 years

First QC Date

December 8, 2009

Last Update Submit

April 1, 2015

Conditions

Obstructive Sleep ApneaHypertension

Keywords

Continuous positive pressure ventilationBlood pressureOxygen desaturation indexEndothelial dysfunctionPatient reported measurement

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Six months

Secondary Outcomes (5)

  • Oxygen desaturation index

    Six months

  • Pulse rate

    Six months

  • Endothelial dysfunction

    Six months

  • Sleep quality and sleepiness

    Six months

  • Health-related quality of life

    Six months

Study Arms (3)

ARB plus increased ARB

ACTIVE COMPARATOR

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

ARB plus CCB

ACTIVE COMPARATOR

angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months

Drug: Olmesartan and Azelnidipine

CCB plus ARB

ACTIVE COMPARATOR

calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months

Drug: Olmesartan and Azelnidipine

Interventions

Olmesartan and AzelnidipineDRUG

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

Also known as: Olmesartan (angiotensin II receptor blockers: ARB), Azelnidipine (long-acting calcium channel blockers: CCB)
ARB plus CCBARB plus increased ARBCCB plus ARB

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kirigaoka Tsuda Hospital

Kitakyushu, Japan

Location

Kyoto University Hospital

Kyoto, Japan

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertension

Interventions

olmesartanazelnidipineAngiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Kazuo Chin, MD, PhD

    Graduate School of Medicine, Kyoto University

    PRINCIPAL INVESTIGATOR

  • Toru Oga, MD, PhD

    Graduate School of Medicine, Kyoto University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 9, 2009

Study Start

July 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

JP(2)