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Completed

NCT Number: NCT00325936

The Effects of Cilnidipine on Metabolic Syndrome Improvement

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cheil general hospital

Seoul, 100-380, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cilnidipine

Drug

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

Other names: Cinalong

Primary outcomes

  1. Homeostasis model assessment of insulin sensitivity (HOMA-IR)

    Time frame: after 3 month and 12 month treatment

  2. Triglyceride/HDL cholesterol ratio

    Time frame: after 3 month and 12 month treatment

Secondary outcomes

  1. Quantitative insulin-sensitivity check index (QUICKI)

    Time frame: after 3 month and 12 month treatment

  2. Resting heart rate

    Time frame: after 3 month and 12 month treatment

  3. Resting norepinephrine

    Time frame: after 3 month and 12 month treatment

  4. Change in abdominal obesity

    Time frame: after 3 month and 12 month treatment

  5. Change in triglyceride

    Time frame: after 3 month and 12 month treatment

  6. Change in cholesterol

    Time frame: after 3 month and 12 month treatment

  7. Decrease in trough SiSBP&SiDBP

    Time frame: after 3 month and 12 month treatment

  8. Change in blood glucose

    Time frame: after 3 month and 12 month treatment

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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]

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 15, 2006
Registry last updated
Aug 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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