Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 12, 2006
First Posted Date  ICMJE May 15, 2006
Last Update Posted Date August 27, 2008
Study Start Date  ICMJE July 2005
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2006)
  • HOMA-IR
  • HDL-Cholesterol ratio
Change History Complete list of historical versions of study NCT00325936 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2006)
  • QUICKI
  • BP
  • etc.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Cilnidipine on Metabolic Syndrome Improvement
Official Title  ICMJE 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]
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Metabolic Syndrome X
Intervention  ICMJE Drug: Cilnidipine
10~20mg, qd, po for 3 months or 12 months.
Other Name: Cinalong
Study Arms  ICMJE
  • Active Comparator: Nifedipine
    parrallel design
    Intervention: Drug: Cilnidipine
  • Experimental: Cilnidipine
    Intervention: Drug: Cilnidipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2008)
186
Original Enrollment  ICMJE
 (submitted: May 12, 2006)
260
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00325936
Other Study ID Numbers  ICMJE CNL-MS-01
SLIMS study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Choi, Jeongeun/Director, Boryung Pharmaceutical Co., Ltd
Study Sponsor  ICMJE Boryung Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Boryung Pharmaceutical Co., Ltd
Verification Date August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP