Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue

NCT ID: NCT02996916

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Olmesartan

Olmesartan 10-40mg daily

Group Type ACTIVE_COMPARATOR

Olmesartan

Intervention Type DRUG

10-40mg daily

Amlodipine

Amlodipine 2.5-10mg daily

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

2.5-10mg daily

Interventions

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Olmesartan

10-40mg daily

Intervention Type DRUG

Amlodipine

2.5-10mg daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Serum creatinine level ≥ 3.0 mg/dL
* Acute or chronic disease
* Allergy to any drugs
* Pregnancy
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kurume University

OTHER

Sponsor Role lead

Responsible Party

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Nobuhiro Tahara

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nobuhiro Tahara, MD, PhD

Role: STUDY_CHAIR

Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine

Locations

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Kurume University Hospital

Kurume, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Nobuhiro Tahara, MD, PhD

Role: CONTACT

Phone: +81-942-31-7580

Email: [email protected]

Facility Contacts

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Nobuhiro Tahara, MD, PhD

Role: primary

Akihiro Honda, MD, PhD

Role: backup

Other Identifiers

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Olme-brain

Identifier Type: -

Identifier Source: org_study_id