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ObesityPhase 3NCT00165685

A Comparative Study of KES524 in Patients With Obesity Disease

A Phase 3 study testing Sibutramine Hydrochloride Monohydrate in people with Obesity, run by Eisai Limited at 20 sites in Japan.

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

To investigate the efficacy and safety of KES524 in patients with obesity (visceral fat obesity with type 2 diabetes and dyslipidemia), a 52-week, double-blind, placebo-controlled comparative study is conducted. Read more about this study

Who is it for?
Ages 20 to 64 years
Conditions the study is for
Obesity
What is being tested?
Sibutramine Hydrochloride Monohydrate
How many people
Not given
Where
20 sitesJapan
Study dates
Jul 2004to Mar 2007
Phase
Phase 3
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 20 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with ≧25 kg/m2 of BMI at the start of the observation period
  • Patients with visceral fat area ≧100 cm2 measured with abdominal CT scan
  • Patients with the following two health impairments:
  • Patients with previously diagnosed type 2 diabetes and HbA1c between ≧6.1% and <9.0% at the start of observation period
  • Patients with ≧150 mg/dL of triglyceride (TG), and/or <40 mg/dL of high-density lipoprotein cholesterol (HDL-C) for serum lipid parameters as dyslipidemic index at the start of the observation period
  • Patients continuously receiving diet therapy for 8 weeks or longer before the start of the observation period
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  • Patients not receiving antidiabetic (12 weeks), antihyperlipidemics (4 weeks) and/or antihypertensive (4 weeks) drugs. If used, those who have received a consistent dosage and administration beginning more than 4 weeks (more than 12 weeks for antidiabetics) before the start of the observation period
  • Patients with ambulatory treatment aged between ≧20 years and <65 years at the time of obtaining informed consent
  • Patients who are given full explanation about the study objective and contents and can give written informed consent

Who cannot join

  • Patients with pulse rate of ≧100/min during the observation period
  • Patients with systolic blood pressure of ≧160 mmHg and/or with diastolic blood pressure of ≧100 mmHg during the observation period
  • Patients with body weight loss of ≧3% as compared to that at the start of the observation period, or body mass index (BMI) that is reduced to <25 kg/m2 during the observation period
  • Patients who have received insulin within 12 weeks before the start of the observation period
  • Patients with present illness or past history of severe eating disorder (e.g., anorexia nervosa or bulimia nervosa)
  • Patients with present illness or past history of drug allergy or severe allergic disease(s)
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  • Patients with present illness or past history of the following disorders:
  • Coronary artery disease (myocardial infarction, angina), heart failure
  • Serious diseases such as cardiovascular (severe tachycardiac heart failure), renal (renal failure), hepatic (severe hepatitis, cirrhosis), pancreatic (severe pancreatitis), psychotic (severe depression, schizophrenia, alcohol addict, drug addict) disorders
  • Pregnant or lactating women, or women who intend to become pregnant during the study period
  • Patients who previously participated in and were treated in another clinical study of KES524
  • Patients who have received another study drug within 24 weeks before starting observation period of this study
  • Patients who are judged to be ineligible for study entry by the investigator or subinvestigator

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Japan20 sites

  • Study site

    Chiba, Chiba, 260-0856

  • Study site

    Chiyoda-ku, Tokyo, 101-0062

  • Study site

    Chiyoda-ku, Tokyo, 102-0071

  • Study site

    Chuo-ku, Tokyo, 103-0026

  • Study site

    Fukushima, Fukushima, 960-1247

  • Study site

    Hachiōji, Tokyo, 193-0944

  • Study site

    Hitachiota, Ibaraki, 313-0014

  • Study site

    Kashiwa, Chiba, 277-0004

  • Study site

    Kōriyama, Fukushima, 963-8022

  • Study site

    Maebashi, Gunma, 371-0034

  • Study site

    Minato-ku, Tokyo, 105-0003

  • Study site

    Mito, Ibaraki, 311-4153

  • Study site

    Naka, Ibaraki, 311-0113

  • Study site

    Sakura, Chiba, 285-0841

  • Study site

    Sendai, Miyagi, 980-0011

  • Study site

    Sendai, Miyagi, 980-0872

  • Study site

    Shibuya-ku, Tokyo, 150-0012

  • Study site

    tabashi City, Tokyo, 173-0032

  • Study site

    Tsuchiura, Ibaraki, 300-0053

  • Study site

    Tsukuba, Ibaraki, 305-0005

Other trials in Japan

About this study

Official title: A Double-Blind, Placebo-Controlled, Comparative Study of KES524 in Patients With Obesity Disease

To investigate the efficacy and safety of KES524 in patients with obesity (visceral fat obesity with type 2 diabetes and dyslipidemia), a 52-week, double-blind, placebo-controlled comparative study is conducted. This study aims to examine superiority of KES524 to placebo by employing change and percent change in body weight (primary endpoints) and changes in proportion of subjects achieving ≧ 5% weight reduction, BMI, waist circumference, visceral fat area, subcutaneous fat area, V/S ratio by abdominal CT scan, HbA1c, TG and HDL-C (secondary endpoints).

Conditions
Obesity
Being tested
Sibutramine Hydrochloride Monohydrate
Medical subject headings
Obesity

What participants receive

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

  • Sibutramine Hydrochloride MonohydrateDrug

What is being measured

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

  1. Change and percent change in body weight

Secondary outcomes (6)

  1. Proportion of subjects achieving ≧5% weight reduction

  2. Change in BMI

  3. Change in waist circumference

  4. Change in visceral fat area, subcutaneous fat area, and V/S ratio by abdominal CT scan

  5. Change in HbA1c

  6. Change and percent change in fasting serum lipids (TG, HDL-C)

Timeline

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

  1. First posted14 Sep 2005 (estimated)
  2. Study startJul 2004
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00165685
Sponsor's protocol ID
KES524-J081-161
Status last verified
Jan 2010
First submitted
12 Sep 2005
Last updated
29 Jan 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sibutramine Hydrochloride Monohydrate in people with Obesity, run by Eisai Limited at 20 sites in Japan.

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 9 inclusion and 13 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 29 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change and percent change in body weight. 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 NCT00165685.

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 29 Jan 2010.

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