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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00288717
• Other study ID #: FUJIYAMA-Study
• Secondary ID: UMIN-CTR-C000000
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2006
• Last updated: January 9, 2007
• Start date: February 2006
• Est. completion date: September 2007

Study information

• Verified date: January 2007
• Source: Saitama Medical University
• Contact: Hidetomo Nakamoto, MD
• Phone: +81-0492-76-1258
• Email: nakamo_h[@]saitama-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Candesartan

• Telmisartan

Locations

Country	Name	City	State
Japan	Saitama Medical School Department of Renal Medicine	Saitama City	Saitama

Sponsors (2)

Lead Sponsor	Collaborator
Saitama Medical University	Non-Profit Organaizaion "LINE"

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Home blood pressure in the early morning
Secondary	Home blood pressure at bedtime
Secondary	M/E ratio
Secondary	Casual blood pressure
Secondary	Body fat percentage
Secondary	Body weight
Secondary	Height
Secondary	BMI
Secondary	Blood potassium
Secondary	Total cholesterol
Secondary	HDL cholesterol
Secondary	LDL cholesterol
Secondary	Triglyceride
Secondary	Blood glucose
Secondary	IRI
Secondary	HbAlc*
Secondary	HOMA-IR
Secondary	Urinary trace albumin
Secondary	Creatinine