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

This study is currently recruiting participants.

Verified by Saitama Medical University, January 2007

First Received: February 7, 2006 Last Updated: January 9, 2007 History of Changes

Sponsor:	Saitama Medical University
Collaborator:	Non-Profit Organaizaion "LINE"
Information provided by:	Saitama Medical University
ClinicalTrials.gov Identifier:	NCT00288717

Purpose

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

Condition	Intervention
Hypertension	Drug: Candesartan Drug: Telmisartan

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: CV 11974 Telmisartan Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Saitama Medical University:

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

Estimated Enrollment:	300
Study Start Date:	February 2006
Estimated Study Completion Date:	September 2007

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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288717

Contacts

Contact: Hidetomo Nakamoto, MD

+81-0492-76-1258

nakamo_h@saitama-med.ac.jp

Locations

Japan, Saitama
Saitama Medical School Department of Renal Medicine	Recruiting
Saitama City, Saitama, Japan, 350-0495
Contact: Hidetomo Nakamoto, MD +81-492-76-1258 nakamo_h@saitama-med.ac.jp
Principal Investigator: Hidetomo Nakamoto, MD

Sponsors and Collaborators

Saitama Medical University

Non-Profit Organaizaion "LINE"

Investigators

Principal Investigator:

Hidetomo Nakamoto, MD

Saitama Medical School Department of Renal Medicine

More Information

No publications provided

Study ID Numbers:	FUJIYAMA-Study, UMIN-CTR-C000000324
Study First Received:	February 7, 2006
Last Updated:	January 9, 2007
ClinicalTrials.gov Identifier:	NCT00288717 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Candesartan cilexetil

Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Candesartan
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Telmisartan
Hypertension

ClinicalTrials.gov processed this record on February 04, 2010