The Effects of Cilnidipine on Metabolic Syndrome Improvement - Full Text View

Purpose

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	Intervention	Phase
Hypertension Metabolic Syndrome X	Drug: Cilnidipine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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]

Resource links provided by NLM:

MedlinePlus related topics: Metabolic Syndrome

Drug Information available for: Nifedipine

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by Boryung Pharmaceutical Co., Ltd:

Primary Outcome Measures:

Homeostasis model assessment of insulin sensitivity (HOMA-IR) [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Triglyceride/HDL cholesterol ratio [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quantitative insulin-sensitivity check index (QUICKI) [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Resting heart rate [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Resting norepinephrine [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Change in abdominal obesity [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Change in triglyceride [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Change in cholesterol [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Decrease in trough SiSBP&SiDBP [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]
Change in blood glucose [ Time Frame: after 3 month and 12 month treatment ] [ Designated as safety issue: No ]


Enrollment:	186
Study Start Date:	July 2005
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	30 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00325936

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
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
Study First Received:	May 12, 2006
Last Updated:	August 26, 2008
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Boryung Pharmaceutical Co., Ltd:


metabolic syndrome Hypertension CCB cilnidipine

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on September 28, 2016