The Effects of Cilnidipine on Metabolic Syndrome Improvement

Phase 4

Completed

• Conditions: Metabolic Syndrome X; Hypertension
• Interventions: Drug: Cilnidipine

• Registration Number: NCT00325936
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

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 Timeline

• Study Start: 2005-07
• Study First Submitted: 2006-05-12
• Study First Submitted QC: 2006-05-12
• Study First Posted: 2006-05-15
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-26
• Last Update Posted: 2008-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nifedipine	Cilnidipine	parrallel design
Cilnidipine	Cilnidipine	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Cheil general hospital; 🇰🇷 Seoul, Korea, Republic of