The Effects of Cilnidipine on Metabolic Syndrome Improvement - Full Text View

Sponsor:	Boryung Pharmaceutical Co., Ltd
Information provided by:	Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:	NCT00325936

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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: Cholesterol High Blood Pressure Metabolic Syndrome

Drug Information available for: Cilnidipine

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 ] [ Designated as safety issue: No ]
Triglyceride/HDL cholesterol ratio [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quantitative insulin-sensitivity check index (QUICKI) [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Resting heart rate [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Resting norepinephrine [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Change in abdominal obesity [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Change in triglyceride [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Change in cholesterol [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Decrease in trough SiSBP&SiDBP [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Change in blood glucose [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]

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
Nifedipine: Active Comparator parrallel design	Drug: Cilnidipine 10~20mg, qd, po for 3 months or 12 months.
Cilnidipine: Experimental	Drug: Cilnidipine 10~20mg, qd, po for 3 months or 12 months.

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

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
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 Ilsan Paik Hospital
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

No publications provided

Responsible Party:	Boryung Pharmaceutical Co., Ltd ( Choi, Jeongeun/Director )
Study ID Numbers:	CNL-MS-01, SLIMS study
Study First Received:	May 12, 2006
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00325936 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Boryung Pharmaceutical Co., Ltd:

metabolic syndrome
Hypertension
CCB
cilnidipine

Additional relevant MeSH terms:

Metabolic Syndrome X
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions
Cilnidipine

Membrane Transport Modulators
Hyperinsulinism
Therapeutic Uses
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Hypertension

ClinicalTrials.gov processed this record on March 18, 2010