The Effects of Cilnidipine on Metabolic Syndrome Improvement

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 Overview

• Status: Completed
• Conditions: Hypertension; Metabolic Syndrome X
• Intervention / Treatment: Drug: Cilnidipine

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: Interventional
• Enrollment (Actual): 186
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 100-380
    • Cheil General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nifedipine; parrallel design	Drug: Cilnidipine; 10~20mg, qd, po for 3 months or 12 months.; Other Names: Cinalong
Experimental: Cilnidipine	Drug: Cilnidipine; 10~20mg, qd, po for 3 months or 12 months.; Other Names: Cinalong

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Homeostasis model assessment of insulin sensitivity (HOMA-IR)	after 3 month and 12 month treatment
Triglyceride/HDL cholesterol ratio	after 3 month and 12 month treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Quantitative insulin-sensitivity check index (QUICKI)	after 3 month and 12 month treatment
Resting heart rate	after 3 month and 12 month treatment
Resting norepinephrine	after 3 month and 12 month treatment
Change in abdominal obesity	after 3 month and 12 month treatment
Change in triglyceride	after 3 month and 12 month treatment
Change in cholesterol	after 3 month and 12 month treatment
Decrease in trough SiSBP&SiDBP	after 3 month and 12 month treatment
Change in blood glucose	after 3 month and 12 month treatment

Collaborators and Investigators

• Sponsor: 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 Ilsan Paik Hospital; 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

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: May 12, 2006
• First Submitted That Met QC Criteria: May 12, 2006
• First Posted (Estimate): May 15, 2006

Study Record Updates

• Last Update Posted (Estimate): August 27, 2008
• Last Update Submitted That Met QC Criteria: August 26, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Hypertension; metabolic syndrome; CCB; cilnidipine
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Hypertension; Syndrome; Metabolic Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Cilnidipine
• Other Study ID Numbers: CNL-MS-01; SLIMS study