EUCTR2005-002454-21-GBActive, not recruitingPhase 1
A 2-Year Study (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of Taranabant (MK-0364) in Obese Patients followed by a 1 year extension. - MK-0364: 1-Yr Weight Loss Followed by 1-Yr Prevention of Weight Regain
Merck Sharp and Dohme Ltd0 sites2,400 target enrollmentStarted: July 4, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 2,400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Body mass index (BMI) between 30 kg/m2 and 43 kg/m2
- •Patient meets at least 1 of the following 4 criteria:
- •Triglyceride levels = 150 mg/dL (1.69 mmol/L) but = 600 mg/dL (6.8 mmol/L)
- •HDL-C levels < 40 mg/dL (1.03 mmol/L) in men and < 50 mg/dL (1.29 mmol/L) in women
- •Seated systolic blood pressure = 130 mm Hg or seated diastolic blood pressure = 85 mm Hg
- •Impaired fasting glucose (FPG = 100 mg/dL [5.5 mmol/L] and < 126 mg/dL [7.0 mmol/L])
- •Patient is = 18 years of age.
- •Patient is highly unlikely to conceive
- •Patient is able to read and understands the study procedures and agrees to participate in the study by giving written informed consent.
- •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
- •Patients with a history or presence of a major DSM-IV-TR psychiatric disorder.
- •Patients with recent (within 6 months prior to screening) diagnosis/episode/ recurrence of stroke or neurological disorder.
- •Patients with inadequately controlled hypertension.
- •Patients with a history of seizures or is at high risk of developing seizures (e.g. those with history of brain tumors, severe head trauma, or intracranial hemorrhage).
- •Patients with 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.
- •Patients with any endocrinopathy, or patient has abnormal TSH at screening
- •Patients with marked hypertriglyceridemia (fasting triglycerides >600 mg/dL [6.8 mmol/L]).
- •Patients with significant cardiovascular disease, active liver disease or a history of chronic liver disease, significant pulmonary disease, significant gastrointestinal disease, significant renal disease or a history of neoplastic disease.
- •Patients who are HIV positive as determined by medical history.
- •Patients who are pregnant or lactating woman, or plan to become pregnant.
- •Patients who have undergone surgical treatment for obesity.
- •Patients with clinically significant abnormalities of laboratory safety tests including :Serum creatinine >1.5 times Upper Limit of Normal (ULN) (>2.1 mg/dL), Serum ALT and/or AST >2 times the ULN(ALT >50 mU/mL; AST >44 mU/mL) and hemoglobin <12.5 gm/dL [7.76 mmol/L] in men and <11.0 gm/dL [6.83 mmol/L] in women.
- •Patients with viral hepatitis (hepatitis B or C).
- •Patient currently uses, or has used within 3 months prior to Visit 1 (Week-3), or plans to use, any prescription or nonprescription drugs, including over-the-counter or herbal preparations (e.g., St. John's Wort), that can alter body weight.
- •Patient treated with fenfluramine, dexfenfluramine either alone or in combination with any other medication at any time.
- •Patients who use or are likely to require long term use of any prescription or nonprescription medication that is a potent or moderate inhibitor of CYP 3A4 or who consume more than 1 quart (four 8 oz. glasses) of grapefruit juice per day at any time during the study..
- •Patients with a history of substance abuse within the past 5 years.
- •Patients who smoke cigarettes or used nicotine-containing products
- •Patients who participated in a weight loss program involving pharmacologic treatment or dietary intervention during the 3 months prior to study start or intend to be involved in any such effort.
- •Patients with clinically significant abnormalities of prestudy electrocardiogram, including but not limited to, prolonged QTc.
Investigators
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