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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2006-004534-32-CZ |
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Date of registration:
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04/10/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase IIb/III Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Obese Patients and in Overweight Patients with Obesity-related Co-morbidities. - A 1 YR STUDY OF MK-0364 IN OBESE/OVERWEIGHT PATIENTS
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Scientific title:
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A Phase IIb/III Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Obese Patients and in Overweight Patients with Obesity-related Co-morbidities. - A 1 YR STUDY OF MK-0364 IN OBESE/OVERWEIGHT PATIENTS |
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Date of first enrolment:
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08/11/2006 |
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Target sample size:
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1000 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004534-32 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Austria
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Czech Republic
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Denmark
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Finland
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France
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Germany
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Men (minimum 25%; targeting 40%) and women with a body mass index (BMI) between 27 kg/m2 and 43 kg/m2, inclusive.
2. Patients must be = 18 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patient has diabetes mellitus as defined by medical history, or a fasting blood glucose =126 mg/dL (7.0 mmol/L) or random blood glucose =200 mg/dL (11.1 mmol/L), or uses oral or injectable antihyperglycemic medications.
2. Patient has a history or presence of a major psychiatric disorder including, but not limited to schizophrenia or other psychotic disorders, major depression, bipolar disorder, generalized anxiety disorder, personality disorder or eating disorder (e.g. bulimia, anorexia disorder).
3. Patient has a history of seizures or is at high risk of developing seizures (e.g., those with history of brain tumors or severe head trauma or intracranial hemorrhage).
4. Patient currently uses or is likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP3A4, or currently uses or plans to use any medication in the medication exclusion list.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Obesity
MedDRA version: 8.1
Level: LLT
Classification code 10027966
Term: Morbid obesity
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Intervention(s)
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Product Name: MK-0364
Product Code: MK-0364
Pharmaceutical Form: Capsule*
INN or Proposed INN: MK-0364
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5, 1, 2-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: In obese patients and in overweight patients with obesity-related co-morbidities, to assess the effects of MK-0364 on:
1. waist circumference at 1 year;
2. percent body fat at 1 year;
3. biochemical markers [triglycerides, HDL-C, LDL-C subclasses, non-HDL-C, LDL-C, total cholesterol, fasting insulin, insulin sensitivity, fasting plasma glucose (FPG), adiponectin and C-reactive protein (CRP)] at 1 year;
4. blood pressure at 1 year;
5. Patient-Reported Outcomes (PRO) at 1 year.
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Main Objective: In obese patients and in overweight patients with obesity-related co-morbidities, to assess the effects of MK-0364 after 1 year of treatment on:
1. body weight;
2. safety and tolerability during treatment.
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Primary end point(s): Body weight.
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Secondary ID(s)
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2006-004534-32-FI
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MK-0364 037
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
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