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]”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2007

- 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

Intervention(s) in this Clinical Trial

• Drug: Cilnidipine
  • 10~20mg, qd, po for 3 months or 12 months.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Nifedipine
  • parrallel design
• Experimental: Cilnidipine

Primary Measures

• Homeostasis model assessment of insulin sensitivity (HOMA-IR)
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No
• Triglyceride/HDL cholesterol ratio
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No

Secondary Measures

• Quantitative insulin-sensitivity check index (QUICKI)
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No
• Resting heart rate
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No
• Resting norepinephrine
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No
• Change in abdominal obesity
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No
• Change in triglyceride
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No
• Change in cholesterol
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No
• Decrease in trough SiSBP&SiDBP
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No
• Change in blood glucose
  • Time Frame: after 3 month and 12 month treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Overall Clinical Trial Officials and Contacts

Jeong Bae Park, Ph.D. Study Chair Cheil General Hospital  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00325936

Study ID Number: CNL-MS-01

ClinicalTrials.gov Identifier: NCT00325936

Health Authority: Korea: Food and Drug Administration