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The Effects of Cilnidipine on Metabolic Syndrome Improvement

NCT ID: NCT00325936

Last Updated: 2008-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-06-30

Brief Summary

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Abnormalities of glucose, insulin and lipoprotein metabolism are common in patients with hypertension, and these metabolic abnormalities are reported to be related to insulin resistance. Therefore, whenever treating such patients, antihypertensive agents that may have the added effect of improving insulin resistance should be selected. CinalongTM (Cilnidipine) is expected to improve metabolic syndrome as well as insulin resistance by its dual effects on L and N-type calcium (Ca) channels. In this study, the researchers investigate the effects of CinalongTM on insulin resistance and other metabolic related factors.

Detailed Description

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* Multi-center, randomized, prospective, double blind, active control, parallel study
* Superiority study (Treatment group - Cilnidipine/Control group - Nifedipine)
* Measure the effects of Cinalong(TM) after 3 month and 12 month-application

Conditions

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Hypertension Metabolic Syndrome X

Keywords

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metabolic syndrome Hypertension CCB cilnidipine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nifedipine

parrallel design

Group Type ACTIVE_COMPARATOR

Cilnidipine

Intervention Type DRUG

10\~20mg, qd, po for 3 months or 12 months.

Cilnidipine

Group Type EXPERIMENTAL

Cilnidipine

Intervention Type DRUG

10\~20mg, qd, po for 3 months or 12 months.

Interventions

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Cilnidipine

10\~20mg, qd, po for 3 months or 12 months.

Intervention Type DRUG

Other Intervention Names

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Cinalong

Eligibility Criteria

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Inclusion Criteria

1. Men or women, 30-65 years of age having essential hypertension with metabolic syndrome
2. At Screening and Visit 1, blood pressure should be: sitting systolic blood pressure (SiSBP) \>=140 mmHg or sitting diastolic blood pressure (SiDBP)\>= 90 mmHg and two or more of the following criteria should apply.

* Abdominal obesity: waist circumference \>= 90 cm in men and \>= 80 cm in women
* Hypertriglyceridemia:. \>=150 mg/dl (1.695 mmol/l)
* Low HDL cholesterol: \< 40 mg/dl (1.036 mmol/l) in men and \< 50 mg/dl (1.295 mmol/l) in women
* High fasting glucose: \>= 110 mg/dl (6.1 mmol/l)

Exclusion Criteria

1. Secondary hypertension
2. Malignant hypertension
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Boryung Pharmaceutical Co., Ltd

Principal Investigators

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Jeong Bae Park, Ph.D.

Role: STUDY_CHAIR

Cheil General Hospital and Women's Healthcare Center

Sang-hyun Lim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University Holy Family Hospital

Ho-joong Youn, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University St Mary's Hospital (Yeouido)

Yeong-geun An, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Dong-su Kim, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Inje University

Seong-yun Lee, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Inje University Ilsan Paik Hospital

Heon-sik Park, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Ji-dong Seong, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

In-ho Chae, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Se-joong Im, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Youngdong Severance Hospital

Locations

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Cheil general hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SLIMS study

Identifier Type: -

Identifier Source: secondary_id

CNL-MS-01

Identifier Type: -

Identifier Source: org_study_id