The Effects of Cilnidipine on Metabolic Syndrome Improvement

• ClinicalTrials.gov Identifier: NCT00325936
• Recruitment Status: Completed
• First Posted: May 15, 2006
• Last Update Posted: August 27, 2008
• Sponsor: Boryung Pharmaceutical Co., Ltd
• Information provided by: Boryung Pharmaceutical Co., Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Metabolic Syndrome X	Drug: Cilnidipine	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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]
• Study Start Date: July 2005
• Actual Primary Completion Date: June 2007
• Actual Study Completion Date: June 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Homeostasis model assessment of insulin sensitivity (HOMA-IR) [ Time Frame: after 3 month and 12 month treatment ]
2. Triglyceride/HDL cholesterol ratio [ Time Frame: after 3 month and 12 month treatment ]

Secondary Outcome Measures :

1. Quantitative insulin-sensitivity check index (QUICKI) [ Time Frame: after 3 month and 12 month treatment ]
2. Resting heart rate [ Time Frame: after 3 month and 12 month treatment ]
3. Resting norepinephrine [ Time Frame: after 3 month and 12 month treatment ]
4. Change in abdominal obesity [ Time Frame: after 3 month and 12 month treatment ]
5. Change in triglyceride [ Time Frame: after 3 month and 12 month treatment ]
6. Change in cholesterol [ Time Frame: after 3 month and 12 month treatment ]
7. Decrease in trough SiSBP&SiDBP [ Time Frame: after 3 month and 12 month treatment ]
8. Change in blood glucose [ Time Frame: after 3 month and 12 month treatment ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Cheil general hospital

Seoul, Korea, Republic of, 100-380

Sponsors and Collaborators

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
• 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

More Information

• Responsible Party: Choi, Jeongeun/Director, Boryung Pharmaceutical Co., Ltd
• ClinicalTrials.gov Identifier: NCT00325936 History of Changes
• Other Study ID Numbers: CNL-MS-01; SLIMS study
• First Posted: May 15, 2006
• Last Update Posted: August 27, 2008
• Last Verified: August 2008

Keywords provided by Boryung Pharmaceutical Co., Ltd:

metabolic syndrome; Hypertension; CCB; cilnidipine

Additional relevant MeSH terms:

Hypertension; Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nifedipine; Cilnidipine; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Tocolytic Agents; Reproductive Control Agents