The Effects of Cilnidipine on Metabolic Syndrome Improvement

Study Overview
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Brief Summary
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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
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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

Official Title
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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]

Conditions
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Hypertension, Metabolic Syndrome X

Intervention / Treatment
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* Drug: Cilnidipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women, 30-65 years of age having essential hypertension with metabolic syndrome 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: Secondary hypertension Malignant hypertension

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nifedipine<br>parrallel design | Drug: Cilnidipine<br>* 10 20mg, qd, po for 3 months or 12 months.<br>* Other names: Cinalong;|
| Experimental: Cilnidipine<br> | Drug: Cilnidipine<br>* 10 20mg, qd, po for 3 months or 12 months.<br>* Other names: Cinalong;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, Hypertension, CCB, cilnidipine