ObesityPhase 3NCT00396448
Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.
A Phase 3 study testing CP-945,598 Treatment B and CP-945,598 Treatment A in people with Obesity, run by Pfizer at 61 sites in 11 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 B and CP-945,598 Treatment A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,253 participants
- Where
- 61 sitesin 11 countries
- Study dates
- Feb 2007to Feb 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/m ; > or = 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
61 sites in 11 countries.
61 sites in 11 countries
United States15 sites
Pfizer Investigational Site
Anderson, South Carolina, 29621
Pfizer Investigational Site
Bountiful, Utah, 84010
Pfizer Investigational Site
Cary, North Carolina, 27518
Pfizer Investigational Site
Farmington Hills, Michigan, 48336
Pfizer Investigational Site
Johnson City, Tennessee, 37601
Pfizer Investigational Site
Louisville, Kentucky, 40217
Pfizer Investigational Site
Miami, Florida, 33143
Pfizer Investigational Site
Newport Beach, California, 92660-2452
Pfizer Investigational Site
Overland Park, Kansas, 66202
Pfizer Investigational Site
Peoria, Arizona, 85381
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Raleigh, North Carolina, 27609
Pfizer Investigational Site
Springfield, Illinois, 62704
Pfizer Investigational Site
Wilmington, North Carolina, 28401
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Australia7 sites
Pfizer Investigational Site
Caboolture, Queensland, 4510
Pfizer Investigational Site
Caringbah, New South Wales, 2229
Pfizer Investigational Site
Clayton, Victoria, 3168
Pfizer Investigational Site
Heidelberg, Victoria, 3081
Pfizer Investigational Site
Kippa-Ring, Queensland, 4020
Pfizer Investigational Site
Miranda, New South Wales, 2228
Pfizer Investigational Site
Wollongong, New South Wales, 2500
Argentina6 sites
Pfizer Investigational Site
Buenos Aires, C1437JCP
Pfizer Investigational Site
Capital Federal, Buenos Aires, 1428
Pfizer Investigational Site
Capital Federal, C1181ACH
Pfizer Investigational Site
Córdoba, Córdoba Province, X5000IUG
Pfizer Investigational Site
Ramos Mejía, Buenos Aires, 1704
Pfizer Investigational Site
Villa Carlos Paz, Córdoba Province, X5152HQC
France6 sites
Pfizer Investigational Site
Armentières, 59427
Pfizer Investigational Site
Lorient, 56322
Pfizer Investigational Site
Paris, 75877
Pfizer Investigational Site
Poitiers, 86021
Pfizer Investigational Site
Rennes, 35033
Pfizer Investigational Site
Strasbourg, 67098
Germany6 sites
Pfizer Investigational Site
Berlin, 13125
Pfizer Investigational Site
Frankfurt am Main, 60316
Pfizer Investigational Site
Hamburg, 20253
Pfizer Investigational Site
Leipzig, 04109
Pfizer Investigational Site
Mannheim, 68163
Pfizer Investigational Site
München, 81675
United Kingdom6 sites
Pfizer Investigational Site
Bath, BA1 3NG
Pfizer Investigational Site
Bath, BA2 4BY
Pfizer Investigational Site
Luton, LU4 0DZ
Pfizer Investigational Site
Northwood, Middlesex, HA6 2RN
Pfizer Investigational Site
Warminster, Wiltshire, BA12 9AA
Pfizer Investigational Site
Watford, Herts, WD25 0EA
Spain5 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Madrid, Madrid, 28007
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Santiago de Compostela, La Coruña, 15706
Pfizer Investigational Site
Valencia, Valencia, 46009
South Korea4 sites
Pfizer Investigational Site
Seoul, 100-032
Pfizer Investigational Site
Seoul, 133-792
Pfizer Investigational Site
Seoul, 137-041
Pfizer Investigational Site
Seoul, 138-736
Sweden3 sites
Pfizer Investigational Site
Gothenburg, 413 45
Pfizer Investigational Site
Stockholm, 141 86
Pfizer Investigational Site
Uppsala, 751 25
Chile2 sites
Pfizer Investigational Site
Santiago, RM, 7560356
Pfizer Investigational Site
Santiago, RM, 7600746
Mexico1 site
Pfizer Investigational Site
San Luis Potosí City, San Luis Potosí, 78200
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 B, CP-945,598 Treatment A, 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 BDrug
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
CP-945,598 Treatment ADrug
Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.
PlaceboDrug
Subjects receive placebo plus dietary, physical activity, and behavioral counseling.
| Study group | Role | What they receive |
|---|---|---|
| CP-945,598 Treatment B | Experimental | Not described Receives: Drug: CP-945,598 Treatment B |
| CP-945,598 Treatment A | Experimental | Not described Receives: Drug: CP-945,598 Treatment A |
| 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.
Change in body weight and proportion of subjects with 5% weight loss
Measured: 1 year
Secondary outcomes (1)
Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startFeb 2007
- Primary completionFeb 2009
- Study completionFeb 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
- 1,253 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
- NCT00396448
- Sponsor's protocol ID
- A5351019
- Status last verified
- Nov 2012
- First submitted
- 6 Nov 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
- NCT00396448
- Acronym / sponsor ID
- A5351019
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 1,253 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 7 Nov 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 B | Experimental | Drug: CP-945,598 Treatment B |
| CP-945,598 Treatment A | Experimental | Drug: CP-945,598 Treatment A |
| 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/m ; > or = 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 BSubjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling. | Drug | CP-945,598 Treatment B |
| CP-945,598 Treatment ASubjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling. | Drug | CP-945,598 Treatment A |
| PlaceboSubjects receive placebo plus dietary, physical activity, and behavioral counseling. | Drug | Placebo |
Primary outcome
Change in body weight and proportion of subjects with 5% weight loss
Time frame: 1 year
1 secondary outcome
Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK
Time frame: 1-2 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.
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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
61 sites in 11 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 B and CP-945,598 Treatment A in people with Obesity, run by Pfizer at 61 sites in 11 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 61 sites in United States, Australia, Argentina, France, Germany and 6 more countries. 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?
Change in body weight and proportion of subjects with 5% weight loss (time frame: 1 year). 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.