Efficacy of Olmesartan on Cerebral Glucose Metabolism, Va... | NCT02996916

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

NCT02996916

Sponsor

Kurume University

Status

Unknown status

Last Update Posted

Dec 20, 2016Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension

Interventions

Olmesartan
Amlodipine

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Dec 13, 2016

First Submission Date that Met QC Criteria

Dec 14, 2016

First Posted Date

Dec 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2016

Last Update Posted Date

Dec 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Olmesartan	Active Comparator	Olmesartan 10-40mg daily	Drug: Olmesartan
Amlodipine	Active Comparator	Amlodipine 2.5-10mg daily	Drug: Amlodipine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olmesartan	Drug	10-40mg daily	Olmesartan
Amlodipine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nobuhiro Tahara, MD, PhD	Contact	+81-942-31-7580		ntahara@med.kurume-u.ac.jp

Overall Officials

Name	Affiliation	Role
Nobuhiro Tahara, MD, PhD	Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kurume University Hospital	Recruiting	Kurume		830-0011	Japan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C437965	olmesartan
D017311	Amlodipine

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

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Browse Branches

Not provided