Back to resultsEffectiveness of Candesartan and Telmisartan on Morning Hypertension in Japanese Obese Patients
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Candesartan
Telmisartan
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria: Circumference at waist: male ≧85 cm, female ≧90 cm Hypertensive patient with untreated hypertension, and casual blood pressure of systole ≧140 mmHg, or diastole ≧90 mmHg Hypertensive patient with hypertension under treatment, and casual blood pressure of systole ≧130 mmHg, or diastole ≧85 mmHg Exclusion Criteria: Significant hypertensive patient with diastolic blood pressure ≧120 mmHg Malignant hypertensive patient Patient with a contraindication to the study drugs (hypersensitivity, significant hepatic diseases, pregnant woman) Patient with urinary protein (qualitative) ＋～＋＋ Patient with familial hyperlipidemia Other patients judged as ineligible for the study
Sites / Locations
- Saitama Medical School Department of Renal MedicineRecruiting
Outcomes
Primary Outcome Measures
Home blood pressure in the early morning
Secondary Outcome Measures
Home blood pressure at bedtime
M/E ratio
Casual blood pressure
Body fat percentage
Body weight
Height
BMI
Blood potassium
Total cholesterol
HDL cholesterol
LDL cholesterol
Triglyceride
Blood glucose
IRI
HbAlc*
HOMA-IR
Urinary trace albumin
Creatinine
Full Information
NCT ID
NCT00288717
First Posted
February 7, 2006
Last Updated
January 9, 2007
Sponsor
Saitama Medical University
Collaborators
Non-Profit Organaizaion "LINE"
1. Study Identification
Unique Protocol Identification Number
NCT00288717
Brief Title
Effectiveness of Candesartan and Telmisartan on Morning Hypertension in Japanese Obese Patients
Official Title
A Randomized, Comparative Study of the Effects of Candesartan and Telmisartan on the Home Blood Pressure, Glucose and Lipid Metabolism in the Hypertensive Patients With the Accumulation of Visceral Fat by the Central Registration System
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Saitama Medical University
Collaborators
Non-Profit Organaizaion "LINE"
4. Oversight
5. Study Description
Brief Summary
To investigate the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by the newly developed Tele-medicine system
Detailed Description
A randomized, comparative study of the effects of Candesartan and Telmisartan on the home blood pressure, glucose and lipid metabolism in the hypertensive patients with the accumulation of visceral fat by the central registration system
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Candesartan
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Primary Outcome Measure Information:
Title
Home blood pressure in the early morning
Secondary Outcome Measure Information:
Title
Home blood pressure at bedtime
Title
M/E ratio
Title
Casual blood pressure
Title
Body fat percentage
Title
Body weight
Title
Height
Title
BMI
Title
Blood potassium
Title
Total cholesterol
Title
HDL cholesterol
Title
LDL cholesterol
Title
Triglyceride
Title
Blood glucose
Title
IRI
Title
HbAlc*
Title
HOMA-IR
Title
Urinary trace albumin
Title
Creatinine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Circumference at waist: male ≧85 cm, female ≧90 cm
Hypertensive patient with untreated hypertension, and casual blood pressure of systole ≧140 mmHg, or diastole ≧90 mmHg
Hypertensive patient with hypertension under treatment, and casual blood pressure of systole ≧130 mmHg, or diastole ≧85 mmHg
Exclusion Criteria:
Significant hypertensive patient with diastolic blood pressure ≧120 mmHg
Malignant hypertensive patient
Patient with a contraindication to the study drugs (hypersensitivity, significant hepatic diseases, pregnant woman)
Patient with urinary protein (qualitative) ＋～＋＋
Patient with familial hyperlipidemia
Other patients judged as ineligible for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hidetomo Nakamoto, MD
Phone
+81-0492-76-1258
Email
nakamo_h@saitama-med.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hidetomo Nakamoto, MD
Organizational Affiliation
Saitama Medical School Department of Renal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saitama Medical School Department of Renal Medicine
City
Saitama City
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hidetomo Nakamoto, MD
Phone
+81-492-76-1258
Email
nakamo_h@saitama-med.ac.jp
First Name & Middle Initial & Last Name & Degree
Hidetomo Nakamoto, MD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Candesartan and Telmisartan on Morning Hypertension in Japanese Obese Patients
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