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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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2 August 2021 |
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Main ID: |
EUCTR2004-000851-41-ES |
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Date of registration:
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13/10/2004 |
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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 randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, multicenter study evaluating the efficacy and safety of four doses of SR147778 in obese patients
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Scientific title:
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A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, multicenter study evaluating the efficacy and safety of four doses of SR147778 in obese patients |
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Date of first enrolment:
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19/11/2004 |
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Target sample size:
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300 |
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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:2004-000851-41 |
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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): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Finland
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- patients must have a BMI = 30 and = 40 at screening,
- total cholesterolemia (= 3 g/L, i.e. 7.7 mmol/L),
- triglyceridemia (= 7 g/L, i.e. 7.9 mmol/L),
- fasting glycemia (= 1.6 g/L, i.e.8.9 mmol/L),
- hemoglobin A1c (= 8%).
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- patients with concurrent hypertension (systolic blood pressure > 160 mmHg; diastolic
blood pressure > 95 mmHg),
- patients who have a presence of any clinically significant gastrointestinal,
cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory
disease, or any other medical condition that might interfere with the evaluation of
study medication,
- patients who are treated with potent inhibitors of CYP3A4 (itraconazole, nefazodone, saquinavir, ritonavir, ketoconazole) or specific moderate inhibitors (grapefruit juice, clarithromycin, erythromycin, diltiazem and verapamil). Patients with the other inhibitors of CYP3A4 can be included but it is a advised to seek for alternative treatment not affecting CYP3A4 before inclusion.
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 is becoming a major health problem in western societies. Its prevalence is increasing especially in USA, UK, and Germany. Obesity is responsible for increased morbidity and mortality. The comorbid conditions associated with obesity include hypertension, dyslipidemia, type 2 diabetes, coronary heart disease, respiratory dysfunction, sleep apnea, gout, gallbladder disease, osteoarthritis, and cancer.
MedDRA version: 7.0
Level: LLT
Classification code 10029883
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Intervention(s)
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Product Code: SR147778
Pharmaceutical Form: Capsule, soft
CAS Number: 288104-79-0
Current Sponsor code: SR147778
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Product Code: SR147778
Pharmaceutical Form: Capsule, soft
CAS Number: 288104-79-0
Current Sponsor code: SR147778
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To assess the effect of SR147778 on weight loss over a period of 24 weeks when
prescribed with a hypocaloric diet in obese patients.
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Secondary Objective: · To assess the safety and tolerability of SR147778 over a period of 24 weeks when
prescribed with a hypocaloric diet in obese patients.
· To assess the effect of SR147778 on several secondary parameters (such as waist,
metabolic parameters, …) over a period of 24 weeks when prescribed with a hypocaloric diet in obese patients.
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Primary end point(s): - Absolute change from baseline (D-1) in body weight at D168 (= 6 months).
- Percentage of responders at 5% (weight loss ³ 5% from baseline) at D168
- Percentage of responders at 10% (weight loss ³ 10% from baseline) at D168,
- Absolute and relative change from baseline over time by visit
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Secondary ID(s)
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DRI5029
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2004-000851-41-FI
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 16/11/2004
Contact:
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