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The Effects of Cilnidipine on Metabolic Syndrome Improvement

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00325936

First Posted: May 15, 2006

Last Update Posted: August 27, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Boryung Pharmaceutical Co., Ltd

Purpose

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.

Condition	Intervention	Phase
Hypertension Metabolic Syndrome X	Drug: Cilnidipine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multi-Center, Double-Blind, Randomized, Superiority Clinical Study to Compare the Effects of Cilnidipine on Metabolic Syndrome Improvement With Nifedipine GITS in Hypertensive Patients With Metabolic Syndrome (Phase IV) [SLIMS]

Resource links provided by NLM:

MedlinePlus related topics: Metabolic Syndrome

Drug Information available for: Nifedipine

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:

Homeostasis model assessment of insulin sensitivity (HOMA-IR) [ Time Frame: after 3 month and 12 month treatment ]
Triglyceride/HDL cholesterol ratio [ Time Frame: after 3 month and 12 month treatment ]

Secondary Outcome Measures:

Quantitative insulin-sensitivity check index (QUICKI) [ Time Frame: after 3 month and 12 month treatment ]
Resting heart rate [ Time Frame: after 3 month and 12 month treatment ]
Resting norepinephrine [ Time Frame: after 3 month and 12 month treatment ]
Change in abdominal obesity [ Time Frame: after 3 month and 12 month treatment ]
Change in triglyceride [ Time Frame: after 3 month and 12 month treatment ]
Change in cholesterol [ Time Frame: after 3 month and 12 month treatment ]
Decrease in trough SiSBP&SiDBP [ Time Frame: after 3 month and 12 month treatment ]
Change in blood glucose [ Time Frame: after 3 month and 12 month treatment ]


Enrollment:	186
Study Start Date:	July 2005
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Nifedipine parrallel design	Drug: Cilnidipine 10~20mg, qd, po for 3 months or 12 months. Other Name: Cinalong
Experimental: Cilnidipine	Drug: Cilnidipine 10~20mg, qd, po for 3 months or 12 months. Other Name: Cinalong

Detailed Description:

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

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or women, 30-65 years of age having essential hypertension with metabolic syndrome
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:

Secondary hypertension
Malignant hypertension

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325936

Locations


Korea, Republic of
Cheil general hospital
Seoul, Korea, Republic of, 100-380

Sponsors and Collaborators

Boryung Pharmaceutical Co., Ltd

Investigators


Study Chair:	Jeong Bae Park, Ph.D.	Cheil General Hospital and Women’s Healthcare Center
Principal Investigator:	Sang-hyun Lim, Ph.D.	Catholic University Holy Family Hospital
Principal Investigator:	Ho-joong Youn, Ph.D.	Catholic University St Mary's Hospital (Yeouido)
Principal Investigator:	Yeong-geun An, Ph.D.	Chonnam National University Hospital
Principal Investigator:	Dong-su Kim, Ph.D.	Inje University
Principal Investigator:	Seong-yun Lee, Ph.D.	Inje University
Principal Investigator:	Heon-sik Park, Ph.D.	Kyungpook National University
Principal Investigator:	Ji-dong Seong, Ph.D.	Samsung Medical Center
Principal Investigator:	In-ho Chae, Ph.D.	Seoul National University Bundang Hospital
Principal Investigator:	Se-joong Im, Ph.D.	Youngdong Severance Hospital

More Information


Responsible Party:	Choi, Jeongeun/Director, Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:	NCT00325936 History of Changes
Other Study ID Numbers:	CNL-MS-01 SLIMS study
First Submitted:	May 12, 2006
First Posted:	May 15, 2006
Last Update Posted:	August 27, 2008
Last Verified:	August 2008

Keywords provided by Boryung Pharmaceutical Co., Ltd:


metabolic syndrome Hypertension CCB cilnidipine

Additional relevant MeSH terms:


Syndrome Hypertension Metabolic Syndrome X Disease Pathologic Processes Vascular Diseases Cardiovascular Diseases Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders	Metabolic Diseases Nifedipine Cilnidipine Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs

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