TerminatedPhase 4

Switching to Rosuvastatin Versus Adding Ezetimibe to Atorvastatin Versus Doubling the Dose of Atorvastatin in Patients With Hypercholesterolemia and Risk Factors (P03708)

Stopped: Slow enrollment \[HIGH SCREEN FAILURE RATE\]

87 participantsStarted 2004-09-01

Plain-language summary

This study assesses whether adding ezetimibe 10 mg/d to ongoing treatment with atorvastatin 10 mg/d is more effective than switching the subject to treatment with rosuvastatin 10 mg/d or doubling the dose of atorvastatin to 20 mg/d is more effective in achieving goal LDL-cholesterol of \<2.5 mmol/L. Treatment phase is 6 weeks.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years to 75 years of age; * Stabilized on atorvastatin 10 mg daily and by subject reported history had taken at least 80% of daily doses for the 4 weeks preceding Visit 1; * LDL-C concentration greater than or equal to 2.5 mmol/L to less than or equal to 160 mg/dL (less than or equal to 4.1 mmol/L) based on blood specimens taken at Visit 1, using the Friedewald calculation as described in the Protocol,Section 8.8. (The lipid profiles at Visit 3 (baseline) and all subsequent visits were kept "blinded" until data analysis); * Triglyceride concentration of less than 350 mg/dL (less than 3.99 mmol/L) based on blood specimens taken at Visit 1; * Documented atherosclerotic disease, CHD, or diabetes mellitus; * Liver transaminases (ALT, AST) less than 50% above the upper limit of normal, with no active liver disease, and CPK less than 50% above the upper limit of normal as tested in blood specimens taken at Visit 1; * Clinical laboratory tests (CBC, blood chemistries, urinalysis) taken at Visit 1 must have been within normal limits or clinically acceptable to the Investigator; * Had been previously prescribed a cholesterol lowering diet and exercise program at least 4 weeks prior to Visit 1 and had been advised to continue the same diet and exercise program during the study; * Reported a stable weight history for at least 4 weeks prior to randomization at Visit 3 (baseline visit); * Women receiving hormonal therapy, including hormone replacement, any estrog…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent change in LDL-C level from baseline to the study endpoint.

Timeframe: 6 weeks

Trial details

NCT IDNCT00651378

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-06-01

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