HypertensionPhase 4NCT00325936

The Effects of Cilnidipine on Metabolic Syndrome Improvement

A Phase 4 study testing Cilnidipine in people with Hypertension and Metabolic Syndrome X, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Hypertension, Metabolic Syndrome X
What is being tested?: Cilnidipine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 1 siteSouth Korea
Study dates: Jul 2005to Jun 2007
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

Secondary hypertension
Malignant hypertension

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Cheil general hospital
Seoul, 100-380

Other trials in South Korea

About this study

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]

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

Conditions: Hypertension, Metabolic Syndrome X
Being tested: Cilnidipine
Keywords: metabolic syndrome, Hypertension, CCB, cilnidipine
Medical subject headings: Hypertension, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CilnidipineDrug
Also called Cinalong
10~20mg, qd, po for 3 months or 12 months.

Study groups in NCT00325936
Study group	Role	What they receive
Nifedipine	Active comparator	parrallel design Receives: Drug: Cilnidipine
Cilnidipine	Experimental	Not described Receives: Drug: Cilnidipine

What is being measured

The primary outcome is the main question the study is designed to answer.

Homeostasis model assessment of insulin sensitivity (HOMA-IR)
Measured: after 3 month and 12 month treatment
Triglyceride/HDL cholesterol ratio
Measured: after 3 month and 12 month treatment

Secondary outcomes (8)

Quantitative insulin-sensitivity check index (QUICKI)
Measured: after 3 month and 12 month treatment
Resting heart rate
Measured: after 3 month and 12 month treatment
Resting norepinephrine
Measured: after 3 month and 12 month treatment
Change in abdominal obesity
Measured: after 3 month and 12 month treatment
Change in triglyceride
Measured: after 3 month and 12 month treatment
Change in cholesterol
Measured: after 3 month and 12 month treatment
Decrease in trough SiSBP&SiDBP
Measured: after 3 month and 12 month treatment
Change in blood glucose
Measured: after 3 month and 12 month treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Jun 2007

First posted15 May 2006 (estimated)
Study startJul 2005
Primary completionJun 2007
Study completionJun 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00325936
Sponsor's protocol ID: CNL-MS-01
Other IDs: SLIMS study
Status last verified: Aug 2008
First submitted: 12 May 2006
Last updated: 27 Aug 2008
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

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]
ClinicalTrials.gov ID: NCT00325936
Acronym / sponsor ID: CNL-MS-01
Conditions: Hypertension, Metabolic Syndrome X
Keywords: metabolic syndrome, Hypertension, CCB, cilnidipine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Jun 2007 (actual)
Study completion: Jun 2007 (actual)
First posted: 15 May 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Nifedipine	Active comparator	Drug: Cilnidipineparrallel design
Cilnidipine	Experimental	Drug: Cilnidipine

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (2 listed)

Secondary hypertension
Malignant hypertension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CilnidipineAlso: Cinalong10~20mg, qd, po for 3 months or 12 months.	Drug	Cilnidipine, Nifedipine

Primary outcome

Homeostasis model assessment of insulin sensitivity (HOMA-IR)
Time frame: after 3 month and 12 month treatment
Triglyceride/HDL cholesterol ratio
Time frame: after 3 month and 12 month treatment

8 secondary outcomes

Quantitative insulin-sensitivity check index (QUICKI)
Time frame: after 3 month and 12 month treatment
Resting heart rate
Time frame: after 3 month and 12 month treatment
Resting norepinephrine
Time frame: after 3 month and 12 month treatment
Change in abdominal obesity
Time frame: after 3 month and 12 month treatment
Change in triglyceride
Time frame: after 3 month and 12 month treatment
Change in cholesterol
Time frame: after 3 month and 12 month treatment
Decrease in trough SiSBP&SiDBP
Time frame: after 3 month and 12 month treatment
Change in blood glucose
Time frame: after 3 month and 12 month treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2008.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cilnidipine in people with Hypertension and Metabolic Syndrome X, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Homeostasis model assessment of insulin sensitivity (HOMA-IR) (time frame: after 3 month and 12 month treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00325936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2008.