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CompletedNCT00325936Updated Aug 27, 2008

The Effects of Cilnidipine on Metabolic Syndrome Improvement

A Phase 4 interventional study of Cilnidipine in Hypertension and Metabolic Syndrome X, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-08-27.

Sponsored by Boryung Pharmaceutical Co., Ltd · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
186
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Hypertension
  • Metabolic Syndrome X

Keywords

  • metabolic syndrome
  • Hypertension
  • CCB
  • cilnidipine
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 186 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Boryung Pharmaceutical Co., Ltd is the lead sponsor of 139 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Secondary hypertension
  2. Malignant hypertension
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
186 participants (actual)

Study arms

  • Active comparator
    Nifedipine

    parrallel design

    Drug: Cilnidipine

  • Experimental
    Cilnidipine

    Drug: Cilnidipine

Interventions

  • DrugCilnidipine

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

    Also known as: Cinalong

06

What researchers measure

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

07

Study locations

1 site
  • Cheil general hospital
    Seoul, 100-380, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00325936
Lead sponsor
Boryung Pharmaceutical Co., Ltd
First posted
May 15, 2006
Start date
Jul 2005
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Aug 27, 2008

Study contacts

Jeong Bae Park, Ph.D.
study chair · Cheil General Hospital and Women's Healthcare Center
Sang-hyun Lim, Ph.D.
principal investigator · Catholic University Holy Family Hospital
Ho-joong Youn, Ph.D.
principal investigator · Catholic University St Mary's Hospital (Yeouido)
Yeong-geun An, Ph.D.
principal investigator · Chonnam National University Hospital
Dong-su Kim, Ph.D.
principal investigator · Inje University
Seong-yun Lee, Ph.D.
principal investigator · Inje University Ilsan Paik Hospital
Heon-sik Park, Ph.D.
principal investigator · Kyungpook National University Hospital
Ji-dong Seong, Ph.D.
principal investigator · Samsung Medical Center
In-ho Chae, Ph.D.
principal investigator · Seoul National University Bundang Hospital
Se-joong Im, Ph.D.
principal investigator · Youngdong Severance Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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