Effectiveness of Candesartan and Telmisartan on Morning Hypertension in Japanese Obese Patients

January 9, 2007 updated by: Saitama Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Saitama
      • Saitama City, Saitama, Japan, 350-0495
        • Recruiting
        • Saitama Medical School Department of Renal Medicine
        • Contact:
        • Principal Investigator:
          • Hidetomo Nakamoto, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Home blood pressure in the early morning

Secondary Outcome Measures

Outcome Measure
Blood glucose
Body weight
Home blood pressure at bedtime
M/E ratio
Casual blood pressure
Body fat percentage
Height
BMI
Blood potassium
Total cholesterol
HDL cholesterol
LDL cholesterol
Triglyceride
IRI
HbAlc*
HOMA-IR
Urinary trace albumin
Creatinine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saitama Medical University

Collaborators

Non-Profit Organaizaion "LINE"

Investigators

  • Principal Investigator: Hidetomo Nakamoto, MD, Saitama Medical School Department of Renal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

September 1, 2007

Study Registration Dates

First Submitted

February 7, 2006

First Submitted That Met QC Criteria

February 7, 2006

First Posted (Estimate)

February 8, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2007

Last Update Submitted That Met QC Criteria

January 9, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUJIYAMA-Study
  • UMIN-CTR-C000000324

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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