Trial | NCT00325936  Report issue

Title

The Effects of Cilnidipine on Metabolic Syndrome Improvement
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]

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    186
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.
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
Study Started
Jul 31
2005
Primary Completion
Jun 30
2007
Study Completion
Jun 30
2007
Last Update
Aug 27
2008
Estimate

Drug Cilnidipine

10~20mg, qd, po for 3 months or 12 months.

  • Other names: Cinalong

Nifedipine Active Comparator

parrallel design

Cilnidipine Experimental

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
No Results Posted