Clinical trial NCT00325936: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Metabolic Syndrome X
Keywords: metabolic syndrome
Hypertension
CCB
cilnidipine
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2006-05-15
Enrollment: 186
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Homeostasis model assessment of insulin sensitivity (HOMA-IR)
timeFrame: after 3 month and 12 month treatment
measure: Triglyceride/HDL cholesterol ratio
timeFrame: after 3 month and 12 month treatment
Secondary outcomes:
measure: Quantitative insulin-sensitivity check index (QUICKI)
timeFrame: after 3 month and 12 month treatment
measure: Resting heart rate
timeFrame: after 3 month and 12 month treatment
measure: Resting norepinephrine
timeFrame: after 3 month and 12 month treatment
measure: Change in abdominal obesity
timeFrame: after 3 month and 12 month treatment
measure: Change in triglyceride
timeFrame: after 3 month and 12 month treatment
measure: Change in cholesterol
timeFrame: after 3 month and 12 month treatment
measure: Decrease in trough SiSBP&SiDBP
timeFrame: after 3 month and 12 month treatment
measure: Change in blood glucose
timeFrame: after 3 month and 12 month treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cheil general hospital
Study officials:
affiliation: Cheil General Hospital and Women's Healthcare Center
name: Jeong Bae Park, Ph.D.
role: STUDY_CHAIR
affiliation: Catholic University Holy Family Hospital
name: Sang-hyun Lim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University St Mary's Hospital (Yeouido)
name: Ho-joong Youn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Yeong-geun An, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Dong-su Kim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Ilsan Paik Hospital
name: Seong-yun Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Heon-sik Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Ji-dong Seong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: In-ho Chae, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Youngdong Severance Hospital
name: Se-joong Im, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: