Effectiveness of Candesartan and Telmisartan on Morning H... | NCT00288717

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

NCT00288717

Sponsor

Saitama Medical University

Status

Unknown status

Last Update Posted

Jan 11, 2007Estimated

Enrollment

300

Phase

Not Applicable

Conditions

Hypertension

Interventions

Candesartan
Telmisartan

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UMIN-CTR-C000000324

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Sep 2007

First Submitted Date

Feb 7, 2006

First Submission Date that Met QC Criteria

Feb 7, 2006

First Posted Date

Feb 8, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2007

Last Update Posted Date

Jan 11, 2007Estimated

Name	Class
Non-Profit Organaizaion "LINE"	UNKNOWN

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Home blood pressure in the early morning

Secondary Outcomes

Measure	Description	Time Frame
Home blood pressure at bedtime
M/E ratio
Casual blood pressure

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hidetomo Nakamoto, MD	Contact	+81-0492-76-1258		nakamo_h@saitama-med.ac.jp

Overall Officials

Name	Affiliation	Role
Hidetomo Nakamoto, MD	Saitama Medical School Department of Renal Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saitama Medical School Department of Renal Medicine	Recruiting	Saitama	Saitama	350-0495	Japan

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C081643	candesartan
D000077333	Telmisartan

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Candesartan	Drug
Telmisartan	Drug