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

NCT02996916 | Unknown Phase 4 DMC

• 1 other identifier: Olme-brain
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. Although glucose is the principal cerebral energy source, impact of hypertensive treatment on cerebral glucose metabolism is poorly understood.

Conditions

Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT

  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

  6 months of treatment

• Change from baseline in abdominal and muscle fat volume as measured by CT

  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)

  6 months of treatment

Study Arms (2)

Olmesartan

ACTIVE COMPARATOR

Olmesartan 10-40mg daily

Drug: Olmesartan

Amlodipine

ACTIVE COMPARATOR

Amlodipine 2.5-10mg daily

Drug: Amlodipine

Interventions

Olmesartan DRUG

10-40mg daily

Olmesartan

Amlodipine DRUG

2.5-10mg daily

Amlodipine

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kurume University: lead

Study Sites (1)

Kurume University Hospital

Kurume, 830-0011, Japan

RECRUITING

MeSH Terms

Interventions

olmesartan; Amlodipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nobuhiro Tahara, MD, PhD

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

  STUDY CHAIR

Central Study Contacts

Nobuhiro Tahara, MD, PhD

CONTACT

+81-942-31-7580; ntahara@med.kurume-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 19, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

JP (1)