HypercholesterolemiaPhase 4NCT00753779
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
A Phase 4 study testing colesevelam HCl tablets, and simvastatin tablets in people with Hypercholesterolemia, run by Daiichi Sankyo at 14 sites in United States.
Trial summary
The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- colesevelam HCl tablets, and simvastatin tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 14 sitesUnited States
- Study dates
- Nov 2002to Apr 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females
- > or = to 18 years of age
- On a stable dose of simvastatin for 4 or more weeks
- LDL-C > or = to 115 mg/dL and < or = to 250 mg/dL
- TG < 300 mg/dL
- Women are not pregnant or breast-feeding or planning to become pregnant
- Women had a hysterectomy or tubal ligation or are post menopausal or are practicing an acceptable method of contraception
Who cannot join
- BMI > 40
- Allergic to colesevelam HCl
- History of swallowing disorder
- History of gastrointestinal motility disorder
- Any disorder that might interfere with the study
- History of drug or alcohol abuse
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Bartlett, Tennessee
Study site
Castle Rock, Colorado
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Los Angeles, California
Study site
Norfolk, Virginia
Study site
Pembroke Pines, Florida
Study site
Richmond, Virginia
Study site
Rochester, New York
Study site
Seattle, Washington
Study site
St. Petersburg, Florida
About this study
Official title: Efficacy of WelChol® as an Add-on to Simvastatin Therapy
The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- colesevelam HCl tablets, and simvastatin tablets, simvastatin tablets and colesevelam HCl placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colesevelam HCl tablets, and simvastatin tabletsDrug
colesevelam HCl tablets, 6/day simvastatin tablet, 1/day
simvastatin tablets and colesevelam HCl placeboDrug
simvastatin tablet, 1/day; Welchol placebo tablets, 6/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | colesevelam HCl Tablets and simvastatin tablets Receives: Drug: colesevelam HCl tablets, and simvastatin tablets |
| 2 | Placebo comparator | simvastatin and Welchol placebo Receives: Drug: simvastatin tablets and colesevelam HCl placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in LDL-C from baseline to endpoint
Measured: 6 weeks
Secondary outcomes (4)
The absolute change in LDL-C from baseline to endpoint
Measured: 6 weeks
The absolute and % change of total cholesterol
Measured: 6 Weeks
The absolute and % change in triglycerides
Measured: 6 Weeks
The absolute and % change in HDL-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 startNov 2002
- Primary completionJun 2003
- Study completionApr 2005
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753779
- Sponsor's protocol ID
- WEL-405
- Status last verified
- Apr 2015
- First submitted
- 16 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
- Efficacy of WelChol® as an Add-on to Simvastatin Therapy
- ClinicalTrials.gov ID
- NCT00753779
- Acronym / sponsor ID
- WEL-405
- Conditions
- Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Apr 2005 (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 is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: colesevelam HCl tablets, and simvastatin tabletscolesevelam HCl Tablets and simvastatin tablets |
| 2 | Placebo comparator | Drug: simvastatin tablets and colesevelam HCl placebosimvastatin and Welchol placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females
- > or = to 18 years of age
- On a stable dose of simvastatin for 4 or more weeks
- LDL-C > or = to 115 mg/dL and < or = to 250 mg/dL
- TG < 300 mg/dL
Key exclusion criteria (6 listed)
- BMI > 40
- Allergic to colesevelam HCl
- History of swallowing disorder
- History of gastrointestinal motility disorder
- Any disorder that might interfere with the study
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 simvastatin tabletscolesevelam HCl tablets, 6/day simvastatin tablet, 1/day | Drug | 1 |
| simvastatin tablets and colesevelam HCl placebosimvastatin tablet, 1/day; Welchol placebo tablets, 6/day | Drug | 2 |
Primary outcome
The percent change in LDL-C from baseline to endpoint
Time frame: 6 weeks
4 secondary outcomes
The absolute change in LDL-C from baseline to endpoint
Time frame: 6 weeks
The absolute and % change of total cholesterol
Time frame: 6 Weeks
The absolute and % change in triglycerides
Time frame: 6 Weeks
The absolute and % change in HDL-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.
14 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 simvastatin tablets in people with Hypercholesterolemia, run by Daiichi Sankyo at 14 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 7 inclusion and 6 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 14 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?
The percent change in LDL-C from baseline to endpoint (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.