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The Effects of Cilnidipine on Metabolic Syndrome Improvement

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.
 
ClinicalTrials.gov Identifier: NCT00325936
Recruitment Status : Completed
First Posted : May 15, 2006
Last Update Posted : August 27, 2008
Sponsor:
Information provided by:
Boryung Pharmaceutical Co., Ltd

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Metabolic Syndrome X Drug: Cilnidipine Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
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]
Study Start Date : July 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. Quantitative insulin-sensitivity check index (QUICKI) [ Time Frame: after 3 month and 12 month treatment ]
  2. Resting heart rate [ Time Frame: after 3 month and 12 month treatment ]
  3. Resting norepinephrine [ Time Frame: after 3 month and 12 month treatment ]
  4. Change in abdominal obesity [ Time Frame: after 3 month and 12 month treatment ]
  5. Change in triglyceride [ Time Frame: after 3 month and 12 month treatment ]
  6. Change in cholesterol [ Time Frame: after 3 month and 12 month treatment ]
  7. Decrease in trough SiSBP&SiDBP [ Time Frame: after 3 month and 12 month treatment ]
  8. Change in blood glucose [ Time Frame: after 3 month and 12 month treatment ]

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

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
Contacts and Locations
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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
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Korea, Republic of
Cheil general hospital
Seoul, Korea, Republic of, 100-380
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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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 Hospital
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
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Responsible Party: Choi, Jeongeun/Director, Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00325936    
Other Study ID Numbers: CNL-MS-01
SLIMS study
First Posted: May 15, 2006    Key Record Dates
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:
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Hypertension
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
 Glucose Metabolism Disorders
Metabolic Diseases
Cilnidipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs