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The Effects of Cilnidipine on Metabolic Syndrome Improvement

B

Boryung

Status and phase

Completed
Phase 4

Conditions

Hypertension
Metabolic Syndrome X

Treatments

Drug: Cilnidipine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00325936
SLIMS study
CNL-MS-01

Details and patient eligibility

About

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.

Full 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

Enrollment

186 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

186 participants in 2 patient groups

Nifedipine
Active Comparator group
Description:
parrallel design
Treatment:
Drug: Cilnidipine
Cilnidipine
Experimental group
Treatment:
Drug: Cilnidipine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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