Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential HypertensionPhase 4NCT02996916
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
A Phase 4 study testing Olmesartan and Amlodipine in people with Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension, run by Kurume University at 1 site in Japan.
Trial summary
Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a major target of the damaging effects of hypertension. Hypertension has been recognized as the leading cause of dementia as well as the most important risk factor for stroke and vascular cognitive impairment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension
- What is being tested?
- Olmesartan and Amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2015to Dec 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained
- Male and female subjects aged 20 years or older at informed consent
- Essential hypertension who had never received angiotensin II receptor antagonists and calcium channel blockers
Who cannot join
- Secondary hypertension or malignant hypertension
- Diabetes mellitus
- History or evidence of a stroke
- Hepatic or hematologic abnormality
- Mild Cognitive Impairment or Dementia
- Serum potassium level ≥ 5.5 mEq/L
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- Serum creatinine level ≥ 3.0 mg/dL
- Acute or chronic disease
- Allergy to any drugs
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kurume University Hospital
Kurume, 830-0011
Nobuhiro Tahara, MD, PhD, +81-942-31-7580, ntahara@med.kurume-u.ac.jp
Akihiro Honda, MD, PhD, +81-942-31-7580, honda_akihiro@med.kurume-u.ac.jp
About this study
Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a major target of the damaging effects of hypertension. Hypertension has been recognized as the leading cause of dementia as well as the most important risk factor for stroke and vascular cognitive impairment. Although glucose is the principal cerebral energy source, impact of hypertensive treatment on cerebral glucose metabolism is poorly understood.
- Being tested
- Olmesartan, Amlodipine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlmesartanDrug
10-40mg daily
AmlodipineDrug
2.5-10mg daily
| Study group | Role | What they receive |
|---|---|---|
| Olmesartan | Active comparator | Olmesartan 10-40mg daily Receives: Drug: Olmesartan |
| Amlodipine | Active comparator | Amlodipine 2.5-10mg daily Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT
Measured: 6 months of treatment
Secondary outcomes (3)
Change from baseline in vascular inflammation measured by blood-normalized standardized uptake value, known as a target-to-background ratio (TBR) by FDG-PET/CT
Measured: 6 months of treatment
Change from baseline in abdominal and muscle fat volume as measured by CT
Measured: 6 months of treatment
Change from baseline in circulating inflammatory markers including hsCRP (mg/L), adiponectin (µg/mL), ADMA (nmoL/mL), DPP-4 (ng/mL), advanced glycation end products (AGEs, µg/mL) and angiotensin-(1-7) (ng/mL)
Measured: 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential HypertensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kurume University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuhiro Tahara, Kurume University
- Investigators
- Nobuhiro Tahara, MD, PhD, Study chair, Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996916
- Sponsor's protocol ID
- Olme-brain
- Status last verified
- Dec 2016
- First submitted
- 13 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
- ClinicalTrials.gov ID
- NCT02996916
- Acronym / sponsor ID
- Olme-brain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kurume UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Dec 2016 (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.
Hypertension is a leading risk factor for morbidity and mortality worldwide. The brain is a major target of the damaging effects of hypertension. Hypertension has been recognized as the leading cause of dementia as well as the most important risk factor for stroke and vascular cognitive impairment. Although glucose is the principal cerebral energy source, impact of hypertensive treatment on cerebral glucose metabolism is poorly understood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olmesartan | Active comparator | Drug: OlmesartanOlmesartan 10-40mg daily |
| Amlodipine | Active comparator | Drug: AmlodipineAmlodipine 2.5-10mg daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent obtained
- Male and female subjects aged 20 years or older at informed consent
- Essential hypertension who had never received angiotensin II receptor antagonists and calcium channel blockers
Key exclusion criteria (10 listed)
- Secondary hypertension or malignant hypertension
- Diabetes mellitus
- History or evidence of a stroke
- Hepatic or hematologic abnormality
- Mild Cognitive Impairment or Dementia
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 |
|---|---|---|
| Olmesartan10-40mg daily | Drug | Olmesartan |
| Amlodipine2.5-10mg daily | Drug | Amlodipine |
Primary outcome
Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT
Time frame: 6 months of treatment
3 secondary outcomes
Change from baseline in vascular inflammation measured by blood-normalized standardized uptake value, known as a target-to-background ratio (TBR) by FDG-PET/CT
Time frame: 6 months of treatment
Change from baseline in abdominal and muscle fat volume as measured by CT
Time frame: 6 months of treatment
Change from baseline in circulating inflammatory markers including hsCRP (mg/L), adiponectin (µg/mL), ADMA (nmoL/mL), DPP-4 (ng/mL), advanced glycation end products (AGEs, µg/mL) and angiotensin-(1-7) (ng/mL)
Time frame: 6 months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Individual participant dataSharing planned: Undecided
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.
Nobuhiro Tahara, MD, PhD study chair
Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olmesartan and Amlodipine in people with Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension, run by Kurume University at 1 site 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nobuhiro Tahara, MD, PhD (+81-942-31-7580, ntahara@med.kurume-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT (time frame: 6 months of treatment). 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 20 Dec 2016.