ObesityPhase 3NCT00375401
A Long-Term Study To Examine The Effects Of CP-945,598 On Weight Loss And Safety
A Phase 3 study testing CP-945,598 Treatment A and CP-945,598 Treatment B in people with Obesity, run by Pfizer at 82 sites in 2 countries.
Trial summary
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- CP-945,598 Treatment A and CP-945,598 Treatment B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,536 participants
- Where
- 82 sitesin 2 countries
- Study dates
- Oct 2006to Jan 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese adults with a body mass index > or = 30 kg/m2; > or = to 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia
Who cannot join
- Pregnancy
- Diabetes
- Adults with serious or unstable current or past medical conditions
Trial locations and contacts
82 sites in 2 countries.
82 sites in 2 countries
United States74 sites
Pfizer Investigational Site
Akron, Ohio, 44311
Pfizer Investigational Site
Albuquerque, New Mexico, 87108
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Austin, Texas, 78705
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Baltimore, Maryland, 21204
Pfizer Investigational Site
Baton Rouge, Louisiana, 70808
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809
Pfizer Investigational Site
Beaumont, Texas, 77701
Pfizer Investigational Site
Beaver, Pennsylvania, 15009
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Burlington, North Carolina, 27215
Pfizer Investigational Site
Charlotte, North Carolina, 28211
Pfizer Investigational Site
Charlotte, North Carolina, 28277
Pfizer Investigational Site
Charlottesville, Virginia, 22911
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Chicago, Illinois, 60610
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Dallas, Texas, 75390-8858
Pfizer Investigational Site
Edina, Minnesota, 55435
Pfizer Investigational Site
Endwell, New York, 13760
Pfizer Investigational Site
Fairhope, Alabama, 36532
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Fort Worth, Texas, 76135
Pfizer Investigational Site
Fort Worth, Texas, 76137
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Gurnee, Illinois, 60031
Pfizer Investigational Site
Hamilton, New Jersey, 08690
Pfizer Investigational Site
Honolulu, Hawaii, 96814
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Kingston, New York, 12401
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Longmont, Colorado, 80501
Pfizer Investigational Site
Louisville, Kentucky, 40213
Pfizer Investigational Site
Louisville, Kentucky, 40223
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Manlius, New York, 13104
Pfizer Investigational Site
Medford, Oregon, 97504
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Minneapolis, Minnesota, 55415
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Morgantown, West Virginia, 26506-9136
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New York, New York, 10021-7903
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
North Dartmouth, Massachusetts, 02747
Pfizer Investigational Site
Oakland, California, 94609-3223
Pfizer Investigational Site
Olympia, Washington, 98502
Pfizer Investigational Site
Oregon, Wisconsin, 53575
Pfizer Investigational Site
Orlando, Florida, 32809
Pfizer Investigational Site
Pawtucket, Rhode Island, 02860
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Renton, Washington, 98057
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Rochester, New York, 14609
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
San Diego, California, 92130
Pfizer Investigational Site
Santa Ana, California, 92705
Pfizer Investigational Site
Scarborough, Maine, 04074
Pfizer Investigational Site
Troy, Michigan, 48098
Pfizer Investigational Site
Waconia, Minnesota, 55387
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Wichita, Kansas, 67207
Canada8 sites
Pfizer Investigational Site
Calgary, Alberta, T2E 7C5
Pfizer Investigational Site
Charlottetown, Prince Edward Island, C1E 1J7
Pfizer Investigational Site
Hamilton, Ontario, L8L 2X2
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, G2E 2X1
Pfizer Investigational Site
Montreal, Quebec, H2W 1R7
Pfizer Investigational Site
Oakville, Ontario, L6H 3P1
Pfizer Investigational Site
Toronto, Ontario, M4R 2G4
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9
About this study
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
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults
Read the 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.
- Conditions
- Obesity
- Being tested
- CP-945,598 Treatment A, CP-945,598 Treatment B, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-945,598 Treatment ADrug
Arm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling
CP-945,598 Treatment BDrug
Arm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling
PlaceboDrug
Arm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling
| Study group | Role | What they receive |
|---|---|---|
| CP-945,598 Treatment A | Experimental | Not described Receives: Drug: CP-945,598 Treatment A |
| CP-945,598 Treatment B | Experimental | Not described Receives: Drug: CP-945,598 Treatment B |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with 5% weight loss
Measured: 1 year
Change in body weight
Measured: 1 year
Secondary outcomes (1)
Blood pressure, blood lipids and glucose, waist circumference, quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375401
- Sponsor's protocol ID
- A5351025
- Status last verified
- Nov 2012
- First submitted
- 11 Sep 2006
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00375401
- Acronym / sponsor ID
- A5351025
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 2,536 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CP-945,598 Treatment A | Experimental | Drug: CP-945,598 Treatment A |
| CP-945,598 Treatment B | Experimental | Drug: CP-945,598 Treatment B |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese adults with a body mass index > or = 30 kg/m2; > or = to 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia
Key exclusion criteria (3 listed)
- Pregnancy
- Diabetes
- Adults with serious or unstable current or past medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-945,598 Treatment AArm includes CP-945,598 Treatment A plus Dietary, Physical Activity, and Weight Loss Counseling | Drug | CP-945,598 Treatment A |
| CP-945,598 Treatment BArm includes CP-945,598 Treatment B plus Dietary, Physical Activity, and Weight Loss Counseling | Drug | CP-945,598 Treatment B |
| PlaceboArm includes Placebo plus Dietary, Physical Activity, and Weight Loss Counseling | Drug | Placebo |
Primary outcome
Proportion of subjects with 5% weight loss
Time frame: 1 year
Change in body weight
Time frame: 1 year
1 secondary outcome
Blood pressure, blood lipids and glucose, waist circumference, quality of life
Time frame: 2 years
Results and safety
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
82 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CP-945,598 Treatment A and CP-945,598 Treatment B in people with Obesity, run by Pfizer at 82 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: See termination reason in detailed description.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with 5% weight loss (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2012.