Back to resultsEfficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
Primary Purpose
Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Olmesartan
Amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension
Eligibility Criteria
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
Sites / Locations
- Kurume University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Olmesartan
Amlodipine
Arm Description
Olmesartan 10-40mg daily
Amlodipine 2.5-10mg daily
Outcomes
Primary Outcome Measures
Effects of treatment on the nominal change in cerebral glucose metabolism from baseline after 6 months of treatment as measured by FDG-PET/CT
Secondary Outcome Measures
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
Change from baseline in abdominal and muscle fat volume as measured by CT
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02996916
Brief Title
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
Official Title
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kurume University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Olmesartan
Arm Type
Active Comparator
Arm Description
Olmesartan 10-40mg daily
Arm Title
Amlodipine
Arm Type
Active Comparator
Arm Description
Amlodipine 2.5-10mg daily
Intervention Type
Drug
Intervention Name(s)
Olmesartan
Intervention Description
10-40mg daily
Intervention Type
Drug
Intervention Name(s)
Amlodipine
Intervention Description
2.5-10mg daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Change from baseline in abdominal and muscle fat volume as measured by CT
Time Frame
6 months of treatment
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nobuhiro Tahara, MD, PhD
Phone
+81-942-31-7580
Email
ntahara@med.kurume-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuhiro Tahara, MD, PhD
Organizational Affiliation
Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuhiro Tahara, MD, PhD
Phone
+81-942-31-7580
Email
ntahara@med.kurume-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Akihiro Honda, MD, PhD
Phone
+81-942-31-7580
Email
honda_akihiro@med.kurume-u.ac.jp
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
We'll reach out to this number within 24 hrs