The Effects of Cilnidipine on Metabolic Syndrome Improvement

This study has been completed.
Sponsor:
Information provided by:
Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT00325936
First received: May 12, 2006
Last updated: August 26, 2008
Last verified: August 2008
  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
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:


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
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

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

No publications provided

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
Study First Received: May 12, 2006
Last Updated: August 26, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Boryung Pharmaceutical Co., Ltd:
metabolic syndrome
Hypertension
CCB
cilnidipine

Additional relevant MeSH terms:
Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Nifedipine
Cilnidipine
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on April 17, 2014