The Effects of Cilnidipine on Metabolic Syndrome Improvement
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ClinicalTrials.gov Identifier: NCT00325936 |
Recruitment Status :
Completed
First Posted : May 15, 2006
Last Update Posted : August 27, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension Metabolic Syndrome X | Drug: Cilnidipine | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Nifedipine
parrallel design
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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 |
- Homeostasis model assessment of insulin sensitivity (HOMA-IR) [ Time Frame: after 3 month and 12 month treatment ]
- Triglyceride/HDL cholesterol ratio [ Time Frame: after 3 month and 12 month treatment ]
- Quantitative insulin-sensitivity check index (QUICKI) [ Time Frame: after 3 month and 12 month treatment ]
- Resting heart rate [ Time Frame: after 3 month and 12 month treatment ]
- Resting norepinephrine [ Time Frame: after 3 month and 12 month treatment ]
- Change in abdominal obesity [ Time Frame: after 3 month and 12 month treatment ]
- Change in triglyceride [ Time Frame: after 3 month and 12 month treatment ]
- Change in cholesterol [ Time Frame: after 3 month and 12 month treatment ]
- Decrease in trough SiSBP&SiDBP [ Time Frame: after 3 month and 12 month treatment ]
- Change in blood glucose [ Time Frame: after 3 month and 12 month treatment ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325936
Korea, Republic of | |
Cheil general hospital | |
Seoul, Korea, Republic of, 100-380 |
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 |
Responsible Party: | Choi, Jeongeun/Director, Boryung Pharmaceutical Co., Ltd |
ClinicalTrials.gov Identifier: | NCT00325936 |
Other Study ID Numbers: |
CNL-MS-01 SLIMS study |
First Posted: | May 15, 2006 Key Record Dates |
Last Update Posted: | August 27, 2008 |
Last Verified: | August 2008 |
metabolic syndrome Hypertension CCB cilnidipine |
Hypertension Metabolic Syndrome Syndrome Disease Pathologic Processes Vascular Diseases Cardiovascular Diseases Insulin Resistance Hyperinsulinism |
Glucose Metabolism Disorders Metabolic Diseases Cilnidipine Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs |