HypercholesterolemiaPhase 4NCT00754039
Study to Compare Welchol and TriCor to TriCor Alone in Patients With High Cholesterol
A Phase 4 study testing colesevelam HCl tablets and fenofibrate tablets in people with Hypercholesterolemia and Hyperlipidemia, Familial Combined, run by Daiichi Sankyo at 10 sites in United States.
Trial summary
The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Hypercholesterolemia, Hyperlipidemia, Familial Combined
- What is being tested?
- colesevelam HCl tablets and fenofibrate tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 10 sitesUnited States
- Study dates
- Feb 2003to Mar 2004
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30-70 years of age
- History of mixed hyperlipidemia
- Prescribed a Step 1 diet at least 30 days prior to screening
- Women were not pregnant, breast-feeding, or plan to become pregnant during the study
- Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures
- Serum LDL-C >/= 115 mg/dL; Serum TG >/= 150 \& < 750 mg/dL
Who cannot join
- BMI >40
- HbA1C > 10%
- Type 1 diabetes
- Intolerance to fibrates
- History of intolerance to colesevelam HCl
- History of swallowing disorders or intestinal motility disorders
Show all 9Show fewer
- Any other disorder that might interfere with the conduct of the study
- History of drug or alcohol abuse
- Recent (within 28 days) history of cardiac disease (MI, CHF, CABG, etc.)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Lombard, Illinois
Study site
Longwood, Florida
Study site
Ocala, Florida
Study site
Overland Park, Kansas
Study site
Richmond, Virginia
Study site
San Antonio, Texas
Study site
Stateville, North Carolina
Study site
Winterpark, Florida
About this study
Official title: The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia
The primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.
- Being tested
- colesevelam HCl tablets and fenofibrate tablets, fenofibrate tablets and Welchol placebo tablets
- Keywords
- Mixed hyperlipidemia
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemia, Familial Combined, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colesevelam HCl tablets and fenofibrate tabletsDrug
Colesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day
fenofibrate tablets and Welchol placebo tabletsDrug
fenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day
fenofibrate tablets and Welchol placebo tabletsDrug
fenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Welchol + TriCor Receives: Drug: colesevelam HCl tablets and fenofibrate tablets |
| 2 | Placebo comparator | Welchol + placebo Receives: Drug: fenofibrate tablets and Welchol placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
% change in LDL-C from baseline
Measured: 6 weeks
Secondary outcomes (3)
The absolute change in LDL-C from baseline
Measured: 6 weeks
The absolute change and % change in LDL-C from week -8 (untreated)
Measured: 14 weeks
The percentage of patients who achieved target LDL-C
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startFeb 2003
- Primary completionSep 2003
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754039
- Sponsor's protocol ID
- WEL-403
- Status last verified
- Apr 2015
- First submitted
- 15 Sep 2008
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Combination of Welchol and Tricor Compared to TriCor Alone in Patients With Mixed Hyperlipidemia
- ClinicalTrials.gov ID
- NCT00754039
- Acronym / sponsor ID
- WEL-403
- Keywords
- Mixed hyperlipidemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 17 Sep 2008 (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 primary objective of this study is to compare the effect of Welchol in combination with TriCor compared to TriCor alone on low-density lipoprotein cholesterol (LDL-C) in patients with high cholesterol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: colesevelam HCl tablets and fenofibrate tabletsWelchol + TriCor |
| 2 | Placebo comparator | Drug: fenofibrate tablets and Welchol placebo tabletsWelchol + placebo |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 30-70 years of age
- History of mixed hyperlipidemia
- Prescribed a Step 1 diet at least 30 days prior to screening
- Women were not pregnant, breast-feeding, or plan to become pregnant during the study
- Women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures
Key exclusion criteria (9 listed)
- BMI >40
- HbA1C > 10%
- Type 1 diabetes
- Intolerance to fibrates
- History of intolerance to colesevelam HCl
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 |
|---|---|---|
| colesevelam HCl tablets and fenofibrate tabletsColesevelam 625 mg tablets - 6 tablets/day Fenofibrate 160 mg tablet - 1/day | Drug | 1 |
| fenofibrate tablets and Welchol placebo tabletsfenofibrate tablets 160 mg - 1/day + Welchol placebo tablets - 6/day | Drug | 2 |
| fenofibrate tablets and Welchol placebo tabletsfenofibrate 160 mg tablet - 1/day and Welchol placebo tablets - 6/day | Drug | 2 |
Primary outcome
% change in LDL-C from baseline
Time frame: 6 weeks
3 secondary outcomes
The absolute change in LDL-C from baseline
Time frame: 6 weeks
The absolute change and % change in LDL-C from week -8 (untreated)
Time frame: 14 weeks
The percentage of patients who achieved target LDL-C
Time frame: 6 Weeks
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 3 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing colesevelam HCl tablets and fenofibrate tablets in people with Hypercholesterolemia and Hyperlipidemia, Familial Combined, run by Daiichi Sankyo at 10 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 6 inclusion and 9 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
% change in LDL-C from baseline (time frame: 6 weeks). 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 3 Apr 2015.