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

Kurume University

Status and phase: Unknown; Phase 4

Conditions: Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension

Treatments: Drug: Olmesartan; Drug: Amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT02996916

Olme-brain

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Olmesartan

Active Comparator group

Description:

Olmesartan 10-40mg daily

Treatment:

Drug: Olmesartan

Amlodipine

Active Comparator group

Description:

Amlodipine 2.5-10mg daily

Treatment:

Drug: Amlodipine