Obstructive Sleep ApneaNCT01028534
Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)
A study testing Olmesartan and Azelnidipine in people with Obstructive Sleep Apnea and Hypertension, run by Kyoto University, Graduate School of Medicine at 2 sites in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Hypertension
- What is being tested?
- Olmesartan and Azelnidipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesJapan
- Study dates
- Jul 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Being tested
- Olmesartan and Azelnidipine
- Keywords
- Continuous positive pressure ventilation, Blood pressure, Oxygen desaturation index, Endothelial dysfunction, Patient reported measurement
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olmesartan and AzelnidipineDrug
Also called Olmesartan (angiotensin II receptor blockers: ARB), Azelnidipine (long-acting calcium channel blockers: CCB)
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Olmesartan and Azelnidipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: Six months
Secondary outcomes (5)
Oxygen desaturation index
Measured: Six months
Pulse rate
Measured: Six months
Endothelial dysfunction
Measured: Six months
Sleep quality and sleepiness
Measured: Six months
Health-related quality of life
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJul 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toru Oga, Kyoto University, Graduate School of Medicine
- Investigators
- Kazuo Chin, MD, PhD, Principal investigator, Graduate School of Medicine, Kyoto UniversityToru Oga, MD, PhD, Principal investigator, Graduate School of Medicine, Kyoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028534
- Sponsor's protocol ID
- C359kyoto
- Status last verified
- Apr 2015
- First submitted
- 8 Dec 2009
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01028534
- Acronym / sponsor ID
- C359kyoto
- Conditions
- Obstructive Sleep Apnea, Hypertension
- Keywords
- Continuous positive pressure ventilation, Blood pressure, Oxygen desaturation index, Endothelial dysfunction, Patient reported measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARB plus increased ARB | Active comparator | Drug: Olmesartan and Azelnidipineangiotensin II receptor blockers for the first 3 months and increasing dose of angiotensin II receptor blockers for the next 3 months |
| ARB plus CCB | Active comparator | Drug: Olmesartan and Azelnidipineangiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months |
| CCB plus ARB | Active comparator | Drug: Olmesartan and Azelnidipinecalcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olmesartan and AzelnidipineAlso: Olmesartan (angiotensin II receptor blockers: ARB), Azelnidipine (long-acting calcium channel blockers: CCB)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 | Drug | ARB plus CCB, ARB plus increased ARB, CCB plus ARB |
Primary outcome
Blood pressure
Time frame: Six months
5 secondary outcomes
Oxygen desaturation index
Time frame: Six months
Pulse rate
Time frame: Six months
Endothelial dysfunction
Time frame: Six months
Sleep quality and sleepiness
Time frame: Six months
Health-related quality of life
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuo Chin, MD, PhD principal investigator
Graduate School of Medicine, Kyoto University
Toru Oga, MD, PhD principal investigator
Graduate School of Medicine, Kyoto University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olmesartan and Azelnidipine in people with Obstructive Sleep Apnea and Hypertension, run by Kyoto University, Graduate School of Medicine at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.