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See termination reason in detailed description.
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The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.
The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Non-pharmacological weight loss program (NPP) | Other |
| |
| Low Calorie Diet | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-945,598 | Drug | CP-945,598 |
| |
| Non-pharmacological weight loss program (NPP) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent weight regained during the 12 month treatment period after a prior weight loss on the low calorie diet (8 weeks). | 14 months |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the effect of CP 954, 598 on: Waist circumference | 14 months | |
| To evaluate the safety and tolerability of CP 945,598 urine and blood tests | 14 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | La Jolla | California | 92037 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Behavioral |
Nutrition counseling, exercise monitoring and behavioral management will occur for all arms during the NPP. |
|
| Low Calorie Diet | Behavioral | Low calorie diet |
|
| To explore the effect of CP 954, 598 on: Pharmacodynamic measurements including fasting insulin, fasting plasma glucose, adiponectin |
| 14 months |
| To explore the effect of CP 954, 598 on: Patient reported outcomes: Power of Food Scale and Three factor Eating Scale | 14 months |
| To explore the effect of CP 954, 598 GAD 7 and PHQ 9 self report questionnaires. and C-SSRS semi structured interview | 14 months |
| Denver |
| Colorado |
| 80220 |
| United States |
| Pfizer Investigational Site | Baton Rouge | Louisiana | 70808 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02118 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | New York | New York | 10021-7903 | United States |
| Pfizer Investigational Site | Durham | North Carolina | 27710 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98108 | United States |
| Pfizer Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| Pfizer Investigational Site | Kippa-Ring | Queensland | 4021 | Australia |
| Pfizer Investigational Site | Adelaide | South Australia | 5000 | Australia |
| Pfizer Investigational Site | Bedford Park | South Australia | 5042 | Australia |
| Pfizer Investigational Site | Heidelberg | Victoria | 3081 | Australia |
| Pfizer Investigational Site | Aarhus | 8000 | Denmark |
| Pfizer Investigational Site | Frederiksberg C | 1958 | Denmark |
| Pfizer Investigational Site | Gentofte Municipality | 2820 | Denmark |
| Pfizer Investigational Site | Roskilde | 4000 | Denmark |
| Pfizer Investigational Site | Almere Stad | 1311 RL | Netherlands |
| Pfizer Investigational Site | Amsterdam | 1081 HV | Netherlands |
| Pfizer Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| Pfizer Investigational Site | Hilversum | 1213 RH | Netherlands |
| Pfizer Investigational Site | Cape Town | Gauteng | 7708 | South Africa |
| Pfizer Investigational Site | Johannesburg | Gauteng | 7500 | South Africa |
| Pfizer Investigational Site | Pretoria | Gauteng | 0157 | South Africa |
| Pfizer Investigational Site | Pretoria | South Africa |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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