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The Effects of Cilnidipine on Metabolic Syndrome Improvement

Information source: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Metabolic Syndrome X

Intervention: Cilnidipine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boryung Pharmaceutical Co., Ltd

Official(s) and/or principal investigator(s):
Jeong Bae Park, Ph.D., Study Chair, Affiliation: Cheil General Hospital and Women’s Healthcare Center
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
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Homeostasis model assessment of insulin sensitivity (HOMA-IR)

Triglyceride/HDL cholesterol ratio

Secondary outcome:

Quantitative insulin-sensitivity check index (QUICKI)

Resting heart rate

Resting norepinephrine

Change in abdominal obesity

Change in triglyceride

Change in cholesterol

Decrease in trough SiSBP&SiDBP

Change in blood glucose

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

Cheil general hospital, Seoul 100-380, Korea, Republic of
Additional Information

Starting date: July 2005
Last updated: August 26, 2008

Page last updated: August 23, 2015

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