Clincosm LogoSign in Get a demo

Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00396448
Collaborator
(none)
1,253
Enrollment
61
Locations
3
Arms
24
Duration (Months)
20.5
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

Condition or Disease Intervention/Treatment Phase
  • Drug: CP-945,598 Treatment B
  • Drug: CP-945,598 Treatment A
  • Drug: Placebo
 Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1253 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: CP-945,598 Treatment B

Drug: CP-945,598 Treatment B
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
Experimental: CP-945,598 Treatment A

Drug: CP-945,598 Treatment A
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
Placebo Comparator: Placebo

Drug: Placebo
Subjects receive placebo plus dietary, physical activity, and behavioral counseling.

Outcome Measures

Primary Outcome Measures

  1. Change in body weight and proportion of subjects with 5% weight loss [1 year]

Secondary Outcome Measures

  1. Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK [1-2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Obese adults with a body mass index > or = 30 kg/m ; > or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia
Exclusion Criteria:

  • Pregnancy

  • Diabetes

  • Adults with serious or unstable current or past medical conditions

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Peoria Arizona United States 85381
2 Pfizer Investigational Site Newport Beach California United States 92660-2452
3 Pfizer Investigational Site Miami Florida United States 33143
4 Pfizer Investigational Site Springfield Illinois United States 62704
5 Pfizer Investigational Site Overland Park Kansas United States 66202
6 Pfizer Investigational Site Louisville Kentucky United States 40217
7 Pfizer Investigational Site Farmington Hills Michigan United States 48336
8 Pfizer Investigational Site Cary North Carolina United States 27518
9 Pfizer Investigational Site Raleigh North Carolina United States 27609
10 Pfizer Investigational Site Wilmington North Carolina United States 28401
11 Pfizer Investigational Site Winston-Salem North Carolina United States 27103
12 Pfizer Investigational Site Portland Oregon United States 97210
13 Pfizer Investigational Site Anderson South Carolina United States 29621
14 Pfizer Investigational Site Johnson City Tennessee United States 37601
15 Pfizer Investigational Site Bountiful Utah United States 84010
16 Pfizer Investigational Site Capital Federal Buenos Aires Argentina 1428
17 Pfizer Investigational Site Ramos Mejia Buenos Aires Argentina 1704
18 Pfizer Investigational Site Villa Carlos Paz Cordoba Argentina X5152HQC
19 Pfizer Investigational Site Buenos Aires Argentina C1437JCP
20 Pfizer Investigational Site Capital Federal Argentina C1181ACH
21 Pfizer Investigational Site Cordoba Argentina X5000IUG
22 Pfizer Investigational Site Caringbah New South Wales Australia 2229
23 Pfizer Investigational Site Miranda New South Wales Australia 2228
24 Pfizer Investigational Site Wollongong New South Wales Australia 2500
25 Pfizer Investigational Site Caboolture Queensland Australia 4510
26 Pfizer Investigational Site Kippa Ring Queensland Australia 4020
27 Pfizer Investigational Site Clayton Victoria Australia 3168
28 Pfizer Investigational Site Heidelberg Victoria Australia 3081
29 Pfizer Investigational Site Santiago RM Chile 7560356
30 Pfizer Investigational Site Santiago RM Chile 7600746
31 Pfizer Investigational Site Armentieres France 59427
32 Pfizer Investigational Site Lorient Cedex France 56322
33 Pfizer Investigational Site Paris Cedex 18 France 75877
34 Pfizer Investigational Site Poitiers Cedex France 86021
35 Pfizer Investigational Site Rennes Cedex 9 France 35033
36 Pfizer Investigational Site Strasbourg Cedex France 67098
37 Pfizer Investigational Site Berlin Germany 13125
38 Pfizer Investigational Site Frankfurt am Main Germany 60316
39 Pfizer Investigational Site Hamburg Germany 20253
40 Pfizer Investigational Site Leipzig Germany 04109
41 Pfizer Investigational Site Mannheim Germany 68163
42 Pfizer Investigational Site Muenchen Germany 81675
43 Pfizer Investigational Site Seoul Korea, Republic of 100-032
44 Pfizer Investigational Site Seoul Korea, Republic of 133-792
45 Pfizer Investigational Site Seoul Korea, Republic of 137-041
46 Pfizer Investigational Site Seoul Korea, Republic of 138-736
47 Pfizer Investigational Site San Luis Potosi SLP Mexico 78200
48 Pfizer Investigational Site Santiago de Compostela La Coruña Spain 15706
49 Pfizer Investigational Site Barcelona Spain 08036
50 Pfizer Investigational Site Madrid Spain 28007
51 Pfizer Investigational Site Madrid Spain 28040
52 Pfizer Investigational Site Valencia Spain 46009
53 Pfizer Investigational Site Goteborg Sweden 413 45
54 Pfizer Investigational Site Stockholm Sweden 141 86
55 Pfizer Investigational Site Uppsala Sweden 751 25
56 Pfizer Investigational Site Watford Herts United Kingdom WD25 0EA
57 Pfizer Investigational Site Warminster Wiltshire United Kingdom BA12 9AA
58 Pfizer Investigational Site Bath United Kingdom BA1 3NG
59 Pfizer Investigational Site Bath United Kingdom BA2 4BY
60 Pfizer Investigational Site Luton United Kingdom LU4 0DZ
61 Pfizer Investigational Site Northwood, Middlesex United Kingdom HA6 2RN

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00396448
Other Study ID Numbers:
  • A5351019
First Posted:
Nov 7, 2006
Last Update Posted:
Nov 7, 2012
Last Verified:
Nov 1, 2012

Study Results

No Results Posted as of Nov 7, 2012