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Trial record 5 of 135 for:    OLMESARTAN

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

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ClinicalTrials.gov Identifier: NCT02996916
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
Nobuhiro Tahara, Kurume University

Tracking Information
First Submitted Date  ICMJE December 13, 2016
First Posted Date  ICMJE December 19, 2016
Last Update Posted Date December 20, 2016
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02996916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
  • 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 ]
  • Change from baseline in abdominal and muscle fat volume as measured by CT [ Time Frame: 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) [ Time Frame: 6 months of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
Official Title  ICMJE Efficacy of Olmesartan on Cerebral Glucose Metabolism, Vascular Inflammation and Adipose Tissue
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension
Intervention  ICMJE
  • Drug: Olmesartan
    10-40mg daily
  • Drug: Amlodipine
    2.5-10mg daily
Study Arms  ICMJE
  • Active Comparator: Olmesartan
    Olmesartan 10-40mg daily
    Intervention: Drug: Olmesartan
  • Active Comparator: Amlodipine
    Amlodipine 2.5-10mg daily
    Intervention: Drug: Amlodipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 14, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nobuhiro Tahara, MD, PhD +81-942-31-7580 ntahara@med.kurume-u.ac.jp
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02996916
Other Study ID Numbers  ICMJE Olme-brain
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nobuhiro Tahara, Kurume University
Study Sponsor  ICMJE Kurume University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Nobuhiro Tahara, MD, PhD Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
PRS Account Kurume University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP