ObesityPhase 2/3NCT00134199
A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects
A Phase 2/3 study testing CP-945,598 and sibutramine in people with Obesity, run by Pfizer at 15 sites in United States.
Trial summary
To evaluate the effect of 6-month administration of CP-945,598 on: weight loss and waist circumference, blood pressure, cholesterol, glucose other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-α and hsCRP the relationship between the concentration of the drug on the blood and the above… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- CP-945,598 and sibutramine
- How many people
- 282 participants
- Where
- 15 sitesUnited States
- Study dates
- Mar 2005to Nov 2005
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests
- Body Mass Index (BMI) ³30 and <40 kg/m2, for subjects with no additional
- co morbidities; BMI ³27 kg/m2 and <40 kg/m2, for subjects with co morbidities [history of essential hypertension and/or dyslipidemia defined as high LDL (³160 mg/dL) or high total cholesterol (³240 mg/dL)];
Who cannot join
- Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater.
- Subjects with type 2 diabetes or fasting blood glucose concentration ³126 mg/dL;
- Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa
- Subjects on prescription and non-prescription appetite or weight modifying drugs
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Pfizer Investigational Site
Baton Rouge, Louisiana, 70808
Pfizer Investigational Site
Charlotte, North Carolina, 28211
Pfizer Investigational Site
Clearwater, Florida, 33761
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Dallas, Texas, 75247
Pfizer Investigational Site
Kissimmee, Florida, 34741
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Louisville, Kentucky, 40213
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Orlando, Florida, 32809
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Tacoma, Washington, 98403
Pfizer Investigational Site
Tacoma, Washington, 98418
About this study
Official title: A 6-Month, Randomized, Double-Blind, Placebo And Positive-Controlled Phase 2b Study To Evaluate The Effect Of Various Doses Of CP-945,598 On Weight Loss In Obese Subjects
To evaluate the effect of 6-month administration of CP-945,598 on:
- weight loss and waist circumference,
- blood pressure, cholesterol, glucose
- other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-α and hsCRP
- the relationship between the concentration of the drug on the blood and the above parameters
- physical and psychosocial functioning, weight related symptoms, treatment satisfaction, appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression
- Conditions
- Obesity
- Being tested
- CP-945,598, sibutramine
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-945,598Drug
sibutramineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing
Secondary outcomes (1)
Evaluate the safety and tolerability of CP 945,598 in a 26 week outpatient setting;; -Explore the effect of CP 945,598 on: waist circumference, PD measurements of selected biochemical variables related to energy deficit and weight loss includ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2005 (estimated)
- Study startMar 2005
- Study completionNov 2005
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134199
- Sponsor's protocol ID
- A5351013
- Status last verified
- Apr 2006
- First submitted
- 22 Aug 2005
- Last updated
- 12 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Randomized, Double-Blind, Placebo And Positive-Controlled Phase 2b Study To Evaluate The Effect Of Various Doses Of CP-945,598 On Weight Loss In Obese Subjects
- ClinicalTrials.gov ID
- NCT00134199
- Acronym / sponsor ID
- A5351013
- Conditions
- Obesity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Nov 2005 (actual)
- First posted
- 24 Aug 2005 (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.
To evaluate the effect of 6-month administration of CP-945,598 on:
- weight loss and waist circumference,
- blood pressure, cholesterol, glucose
- other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-α and hsCRP
- the relationship between the concentration of the drug on the blood and the above parameters
- physical and psychosocial functioning, weight related symptoms, treatment satisfaction, appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests
- Body Mass Index (BMI) ³30 and <40 kg/m2, for subjects with no additional
- co morbidities; BMI ³27 kg/m2 and <40 kg/m2, for subjects with co morbidities [history of essential hypertension and/or dyslipidemia defined as high LDL (³160 mg/dL) or high total cholesterol (³240 mg/dL)];
Key exclusion criteria (4 listed)
- Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater.
- Subjects with type 2 diabetes or fasting blood glucose concentration ³126 mg/dL;
- Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa
- Subjects on prescription and non-prescription appetite or weight modifying drugs
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 | Drug | – |
| sibutramine | Drug | – |
Primary outcome
Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing
1 secondary outcome
Evaluate the safety and tolerability of CP 945,598 in a 26 week outpatient setting;; -Explore the effect of CP 945,598 on: waist circumference, PD measurements of selected biochemical variables related to energy deficit and weight loss includ
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2009.
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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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CP-945,598 and sibutramine in people with Obesity, run by Pfizer at 15 sites in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing. 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 12 Aug 2009.