Back to resultsThe Effects of Cilnidipine on Metabolic Syndrome Improvement
Primary Purpose
Hypertension, Metabolic Syndrome X
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilnidipine
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring metabolic syndrome, Hypertension, CCB, cilnidipine
Eligibility 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
Sites / Locations
- Cheil general hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nifedipine
Cilnidipine
Arm Description
parrallel design
Outcomes
Primary Outcome Measures
Homeostasis model assessment of insulin sensitivity (HOMA-IR)
Triglyceride/HDL cholesterol ratio
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00325936
First Posted
May 12, 2006
Last Updated
August 26, 2008
Sponsor
Boryung Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00325936
Brief Title
The Effects of Cilnidipine on Metabolic Syndrome Improvement
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 Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Metabolic Syndrome X
Keywords
metabolic syndrome, Hypertension, CCB, cilnidipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
parrallel design
Arm Title
Cilnidipine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cilnidipine
Other Intervention Name(s)
Cinalong
Intervention Description
10~20mg, qd, po for 3 months or 12 months.
Primary Outcome Measure Information:
Title
Homeostasis model assessment of insulin sensitivity (HOMA-IR)
Time Frame
after 3 month and 12 month treatment
Title
Triglyceride/HDL cholesterol ratio
Time Frame
after 3 month and 12 month treatment
Secondary Outcome Measure Information:
Title
Quantitative insulin-sensitivity check index (QUICKI)
Time Frame
after 3 month and 12 month treatment
Title
Resting heart rate
Time Frame
after 3 month and 12 month treatment
Title
Resting norepinephrine
Time Frame
after 3 month and 12 month treatment
Title
Change in abdominal obesity
Time Frame
after 3 month and 12 month treatment
Title
Change in triglyceride
Time Frame
after 3 month and 12 month treatment
Title
Change in cholesterol
Time Frame
after 3 month and 12 month treatment
Title
Decrease in trough SiSBP&SiDBP
Time Frame
after 3 month and 12 month treatment
Title
Change in blood glucose
Time Frame
after 3 month and 12 month treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Bae Park, Ph.D.
Organizational Affiliation
Cheil General Hospital and Women's Healthcare Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sang-hyun Lim, Ph.D.
Organizational Affiliation
Catholic University Holy Family Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ho-joong Youn, Ph.D.
Organizational Affiliation
Catholic University St Mary's Hospital (Yeouido)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yeong-geun An, Ph.D.
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong-su Kim, Ph.D.
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seong-yun Lee, Ph.D.
Organizational Affiliation
Inje University Ilsan Paik Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heon-sik Park, Ph.D.
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ji-dong Seong, Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
In-ho Chae, Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Se-joong Im, Ph.D.
Organizational Affiliation
Youngdong Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cheil general hospital
City
Seoul
ZIP/Postal Code
100-380
Country
Korea, Republic of
12. IPD Sharing Statement
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The Effects of Cilnidipine on Metabolic Syndrome Improvement
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