HypercholesterolemiaPhase 4NCT00185107
Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol
A Phase 4 study testing Colesevelam Hydrochloride, Ezetimibe and Simvastatin in people with Hypercholesterolemia, run by Daiichi Sankyo at 7 sites in United States.
Trial summary
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Colesevelam Hydrochloride, Ezetimibe and Simvastatin
- How many people
- 45 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2005to Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age, inclusive;
- A history of primary hypercholesterolemia
Who cannot join
- Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
- Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder disease
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Linder Clinical Trial Center
Cincinnati, Ohio, 45219
Radiant Research
Edina, Minnesota, 55435
L-MARC Research Center
Louisville, Kentucky, 40213
Renstar Medical Research
Ocala, Florida, 34471
Radiant Research
Overland Park, Kansas, 66215
Scripps Clinic
San Diego, California, 92128
Medical Office
Statesville, North Carolina, 28677
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Combination With Zetia® Compared to Zetia® Alone in Patients With Primary Hypercholesterolemia
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
- Conditions
- Hypercholesterolemia
- Being tested
- Colesevelam Hydrochloride, Ezetimibe, Simvastatin
- Keywords
- Safety, Efficacy, WelChol®, Zocor®, Zetia®
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colesevelam HydrochlorideDrug
EzetimibeDrug
SimvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in LDL-C from the start of the study
Secondary outcomes (5)
- The absolute change in LDL-C from baseline
- The percent change in LDL-C from baseline
- The absolute changes and percent changes in TG, non-HDL-
C, HDL-C, total cholesterol and other lipid measures
- The percentages of patients who achieve target levels of LDL-C at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2005
- Study completionOct 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
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185107
- Sponsor's protocol ID
- WEL-408
- Status last verified
- Sep 2007
- First submitted
- 9 Sep 2005
- Last updated
- 11 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Combination With Zetia® Compared to Zetia® Alone in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00185107
- Acronym / sponsor ID
- WEL-408
- Conditions
- Hypercholesterolemia
- Keywords
- Safety, Efficacy, WelChol®, Zocor®, Zetia®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Oct 2005
- First posted
- 16 Sep 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.
Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 years of age, inclusive;
- A history of primary hypercholesterolemia
Key exclusion criteria (2 listed)
- Any serious disorders including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/ metabolic, hematologic/oncologic (within the last 5 years), neurologic and psychiatric diseases that would interfere with the conduct of the study or interpretation of the data;
- Hepatic dysfunction including biliary cirrhosis, unexplained persistent liver function abnormality, and pre-existing gallbladder 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 |
|---|---|---|
| Colesevelam Hydrochloride | Drug | – |
| Ezetimibe | Drug | – |
| Simvastatin | Drug | – |
Primary outcome
The percent change in LDL-C from the start of the study
5 secondary outcomes
- The absolute change in LDL-C from baseline
- The percent change in LDL-C from baseline
- The absolute changes and percent changes in TG, non-HDL-
C, HDL-C, total cholesterol and other lipid measures
- The percentages of patients who achieve target levels of LDL-C at the end of the study
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 11 Sep 2007.
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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.
7 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 Hydrochloride, Ezetimibe and Simvastatin in people with Hypercholesterolemia, run by Daiichi Sankyo at 7 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 2 inclusion and 2 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 11 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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 the start of the study. 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 11 Sep 2007.