ObesityPhase 3NCT00231621
A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia
A Phase 3 study testing topiramate in people with Obesity and Hyperlipidemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to compare the efficacy and safety of daily topiramate versus placebo for the treatment of obese subjects with dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Hyperlipidemia, Hypertriglyceridemia
- What is being tested?
- topiramate
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- May 2001to Jun 2002
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A Body Mass Index (BMI) >= 27 kg/m^2 and <50 kg/m^2
- Stable weight at least four months prior to the first enrollment visit
- Diagnosis of dyslipidemia (serum triglycerides representative of mild to moderate hypertriglyceridemia and low HDL or high LDL)
- Patients on lipid lowering medication should be on monotherapy with the same drug for at least 4 months and on the same dose for at least 2 months prior to the first enrollment
- Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
Who cannot join
- Contraindication or hypersensitivity to topiramate
- Pregnancy, nursing or women who plan to become pregnant during the study
- Enrollment fasting triglycerides <175 or >= 1000 mg/dL, and/or LDL >= 190 mg/dL
- Hyperlipidemia secondary to known disease
- Other significant medical conditions such as cardiovascular or liver disease
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, One-year Study of the Efficacy and Safety of Topiramate in the Treatment of Obese Subjects With Dyslipidemia
The purpose of this study is to compare the efficacy and safety of daily topiramate versus placebo for the treatment of obese subjects with dyslipidemia.
Read the detailed description
Topiramate is not approved for the treatment of obesity. Studies have shown that topiramate reduces weight in obese patients with or without Type 2 diabetes, and may have the adjunctive benefit of reducing triglyceride and cholesterol levels in these patients. This double-blind, placebo controlled study evaluates the long-term efficacy of topiramate for reduction of weight and triglyceride levels in obese patients with borderline to high hypertriglyceridemia, and the safety and tolerability of topiramate in this patient population. The study consists of four phases: 4-week enrollment (screening) phase, 8-week titration phase (topiramate dose will be increased from 16mg/day to the assigned dose), 52-week maintenance phase, and 6-week follow-up. Effectiveness of topiramate will be evaluated by multiple measurements such as change in body weight, body mass index, fasting serum triglyceride levels, cholesterol and other lipid profiles. Safety evaluations will include incidence/severity of adverse events, vital signs, clinical laboratory results. The hypothesis is that topiramate as compared to placebo will provide a greater percent reduction in body weight and in fasting serum triglycerides from Week 0 (baseline) to Week 60. After the initial 8-weeks titration phase, the patients will be randomized to receive either 96mg (48mg twice daily) or 192mg (96mg twice daily) topiramate or placebo (twice daily) by mouth for 52 weeks.
- Conditions
- Obesity, Hyperlipidemia, Hypertriglyceridemia
- Being tested
- topiramate
- Keywords
- Obesity, Dyslipidemia, Hyperlipidemia, Triglyceride, HDL, LDL, Diabetes
- Medical subject headings
- Obesity, Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight and the percent change in fasting serum triglycerides from baseline (Week 0) to Week 60.
Secondary outcomes (1)
Absolute change in body weight, body mass index, triglycerides, and absolute and percentage changes in cholesterol measures from baseline to Week 60. Safety evaluations throughout study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startMay 2001
- Study completionJun 2002
Why it stopped: The study was terminated prior to completion to focus on the development of a controlled release formulation.
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.
- 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
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231621
- Sponsor's protocol ID
- CR003730
- Status last verified
- Apr 2010
- First submitted
- 30 Sep 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, One-year Study of the Efficacy and Safety of Topiramate in the Treatment of Obese Subjects With Dyslipidemia
- ClinicalTrials.gov ID
- NCT00231621
- Acronym / sponsor ID
- CR003730
- Conditions
- Obesity, Hyperlipidemia, Hypertriglyceridemia
- Keywords
- Obesity, Dyslipidemia, Hyperlipidemia, Triglyceride, HDL, LDL, Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prior to completion to focus on the development of a controlled release formulation.
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- May 2001
- Study completion
- Jun 2002 (actual)
- First posted
- 4 Oct 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.
The purpose of this study is to compare the efficacy and safety of daily topiramate versus placebo for the treatment of obese subjects with dyslipidemia.
Detailed description
Topiramate is not approved for the treatment of obesity. Studies have shown that topiramate reduces weight in obese patients with or without Type 2 diabetes, and may have the adjunctive benefit of reducing triglyceride and cholesterol levels in these patients. This double-blind, placebo controlled study evaluates the long-term efficacy of topiramate for reduction of weight and triglyceride levels in obese patients with borderline to high hypertriglyceridemia, and the safety and tolerability of topiramate in this patient population. The study consists of four phases: 4-week enrollment (screening) phase, 8-week titration phase (topiramate dose will be increased from 16mg/day to the assigned dose), 52-week maintenance phase, and 6-week follow-up. Effectiveness of topiramate will be evaluated by multiple measurements such as change in body weight, body mass index, fasting serum triglyceride levels, cholesterol and other lipid profiles. Safety evaluations will include incidence/severity of adverse events, vital signs, clinical laboratory results. The hypothesis is that topiramate as compared to placebo will provide a greater percent reduction in body weight and in fasting serum triglycerides from Week 0 (baseline) to Week 60. After the initial 8-weeks titration phase, the patients will be randomized to receive either 96mg (48mg twice daily) or 192mg (96mg twice daily) topiramate or placebo (twice daily) by mouth for 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A Body Mass Index (BMI) >= 27 kg/m^2 and <50 kg/m^2
- Stable weight at least four months prior to the first enrollment visit
- Diagnosis of dyslipidemia (serum triglycerides representative of mild to moderate hypertriglyceridemia and low HDL or high LDL)
- Patients on lipid lowering medication should be on monotherapy with the same drug for at least 4 months and on the same dose for at least 2 months prior to the first enrollment
- Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)
Key exclusion criteria (5 listed)
- Contraindication or hypersensitivity to topiramate
- Pregnancy, nursing or women who plan to become pregnant during the study
- Enrollment fasting triglycerides <175 or >= 1000 mg/dL, and/or LDL >= 190 mg/dL
- Hyperlipidemia secondary to known disease
- Other significant medical conditions such as cardiovascular or liver disease
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 |
|---|---|---|
| topiramate | Drug | – |
Primary outcome
Percent change in body weight and the percent change in fasting serum triglycerides from baseline (Week 0) to Week 60.
1 secondary outcome
Absolute change in body weight, body mass index, triglycerides, and absolute and percentage changes in cholesterol measures from baseline to Week 60. Safety evaluations throughout study.
Results and safety
The study was stopped early (reason given: The study was terminated prior to completion to focus on the development of a controlled release formulation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects with DyslipidemiaLink 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topiramate in people with Obesity and Hyperlipidemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 inclusion and 5 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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 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: The study was terminated prior to completion to focus on the development of a controlled release formulation.). 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?
Percent change in body weight and the percent change in fasting serum triglycerides from baseline (Week 0) to Week 60.. 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 8 Jun 2011.