The Effects of Cilnidipine on Metabolic Syndrome Improvement

Hypertension Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325936
• Other study ID #: CNL-MS-01
• Secondary ID: SLIMS study
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2006
• Last updated: August 26, 2008
• Start date: July 2005
• Est. completion date: June 2007

Study information

• Verified date: August 2008
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Metabolic Syndrome X
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Cheil general hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostasis model assessment of insulin sensitivity (HOMA-IR)		after 3 month and 12 month treatment	No
Primary	Triglyceride/HDL cholesterol ratio		after 3 month and 12 month treatment	No
Secondary	Quantitative insulin-sensitivity check index (QUICKI)		after 3 month and 12 month treatment	No
Secondary	Resting heart rate		after 3 month and 12 month treatment	No
Secondary	Resting norepinephrine		after 3 month and 12 month treatment	No
Secondary	Change in abdominal obesity		after 3 month and 12 month treatment	No
Secondary	Change in triglyceride		after 3 month and 12 month treatment	No
Secondary	Change in cholesterol		after 3 month and 12 month treatment	No
Secondary	Decrease in trough SiSBP&SiDBP		after 3 month and 12 month treatment	No
Secondary	Change in blood glucose		after 3 month and 12 month treatment	No