NCT00325936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 27, 2008

Status Verified

August 1, 2008

Enrollment Period

1.9 years

First QC Date

May 12, 2006

Last Update Submit

August 26, 2008

Conditions

HypertensionMetabolic Syndrome X

Keywords

metabolic syndromeHypertensionCCBcilnidipine

Outcome Measures

Primary Outcomes (2)

  • Homeostasis model assessment of insulin sensitivity (HOMA-IR)

    after 3 month and 12 month treatment

  • Triglyceride/HDL cholesterol ratio

    after 3 month and 12 month treatment

Secondary Outcomes (8)

  • Quantitative insulin-sensitivity check index (QUICKI)

    after 3 month and 12 month treatment

  • Resting heart rate

    after 3 month and 12 month treatment

  • Resting norepinephrine

    after 3 month and 12 month treatment

  • Change in abdominal obesity

    after 3 month and 12 month treatment

  • Change in triglyceride

    after 3 month and 12 month treatment

  • +3 more secondary outcomes

Study Arms (2)

Nifedipine

ACTIVE COMPARATOR

parrallel design

Drug: Cilnidipine

Cilnidipine

EXPERIMENTAL
Drug: Cilnidipine

Interventions

CilnidipineDRUG

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

Also known as: Cinalong
CilnidipineNifedipine

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Secondary hypertension
  • Malignant hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheil general hospital

Seoul, 100-380, South Korea

Location

MeSH Terms

Conditions

HypertensionMetabolic Syndrome

Interventions

cilnidipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jeong Bae Park, Ph.D.

    Cheil General Hospital and Women's Healthcare Center

    STUDY CHAIR

  • Sang-hyun Lim, Ph.D.

    Catholic University Holy Family Hospital

    PRINCIPAL INVESTIGATOR

  • Ho-joong Youn, Ph.D.

    Catholic University St Mary's Hospital (Yeouido)

    PRINCIPAL INVESTIGATOR

  • Yeong-geun An, Ph.D.

    Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

  • Dong-su Kim, Ph.D.

    Inje University

    PRINCIPAL INVESTIGATOR

  • Seong-yun Lee, Ph.D.

    Inje University Ilsan Paik Hospital

    PRINCIPAL INVESTIGATOR

  • Heon-sik Park, Ph.D.

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

  • Ji-dong Seong, Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • In-ho Chae, Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

  • Se-joong Im, Ph.D.

    Youngdong Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

July 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

August 27, 2008

Record last verified: 2008-08

Locations

KR(1)