The Effects of Cilnidipine on Metabolic Syndrome Improvement
Information source: Boryung Pharmaceutical Co., Ltd
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Metabolic Syndrome X
Intervention: Cilnidipine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Boryung Pharmaceutical Co., Ltd Official(s) and/or principal investigator(s):
Jeong Bae Park, Ph.D., Study Chair, Affiliation: Cheil General Hospital
Sang-hyun Lim, Ph.D., Principal Investigator, Affiliation: Catholic University Holy Family Hospital
Ho-joong Youn, Ph.D., Principal Investigator, Affiliation: Catholic University St Mary’s Hospital (Yeouido)
Yeong-geun An, Ph.D., Principal Investigator, Affiliation: Chonnam National University Hospital
Dong-su Kim, Ph.D., Principal Investigator, Affiliation: Inje University
Seong-yun Lee, Ph.D., Principal Investigator, Affiliation: Inje University Ilsan Paik Hospital
Heon-sik Park, Ph.D., Principal Investigator, Affiliation: Kyungpook National University
Ji-dong Seong, Ph.D., Principal Investigator, Affiliation: Samsung Medical Center
In-ho Chae, Ph.D., Principal Investigator, Affiliation: Seoul National University Bundang Hospital
Se-joong Im, Ph.D., Principal Investigator, Affiliation: Youngdong Severance Hospital
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Homeostasis model assessment of insulin sensitivity (HOMA-IR)High density lipoprotein (HDL)-cholesterol ratio
Secondary outcome: Quantitative insulin-sensitivity check index (QUICKI)Blood pressure (BP) etc.
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
Eligibility
Minimum age: 30 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Boryung Pharm. Co.Ltd, Seoul 110-750, Korea, Republic of; Recruiting
Hyeri Cha, Ph.D., Email: hrcha@boryung.co.kr
Youngran Baek, BA, Email: jeanhoo@boryung.co.kr
Additional Information
Starting date: July 2005
Last updated: September 11, 2006
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