HypercholesterolemiaPhase 3NCT00271817

To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

A Phase 3 study testing Comparator: ezetimibe/simvastatin + niacin (ER), Comparator: niacin (ER) tablet and Comparator: ezetimibe (+) simvastatin in people with Hypercholesterolemia, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Hypercholesterolemia
What is being tested?: Comparator: ezetimibe/simvastatin + niacin (ER), Comparator: niacin (ER) tablet and Comparator: ezetimibe (+) simvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,220 participants
Where: No sites listed yet
Study dates: Dec 2005to Feb 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
Patient willing to be on a low-cholesterol diet

Who cannot join

Pregnant or lactating women or intending to become pregnant
Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk

About this study

Official title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Conditions: Hypercholesterolemia
Being tested: Comparator: ezetimibe/simvastatin + niacin (ER), Comparator: Placebo to ezetimibe/simvastatin, Comparator: niacin (ER) tablet, Comparator: ezetimibe (+) simvastatin, Comparator: Placebo to Niacin (ER)
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: ezetimibe/simvastatin + niacin (ER)Drug
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
Comparator: Placebo to ezetimibe/simvastatinDrug
ezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.
Comparator: niacin (ER) tabletDrug
niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks
Comparator: ezetimibe (+) simvastatinDrug
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.
Comparator: Placebo to Niacin (ER)Drug
Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.
Comparator: ezetimibe/simvastatin and niacin (ER)Drug
ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks
Comparator: ezetimibe and simvastatinDrug
ezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks
Comparator: Placebo to niacin (ER)Drug
Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks

Study groups in NCT00271817
Study group	Role	What they receive
Part 1 - Arm 1	Active comparator	ezetimibe/simvastatin combination tablet + niacin (ER) Receives: Drug: Comparator: ezetimibe/simvastatin + niacin (ER)
Part 1 -Arm 2	Active comparator	ezetimibe/simvastatin Receives: Drug: Comparator: ezetimibe (+) simvastatin; Drug: Comparator: Placebo to Niacin (ER)
Part 1 - Arm 3	Active comparator	Niacin (ER) Receives: Drug: Comparator: Placebo to ezetimibe/simvastatin; Drug: Comparator: niacin (ER) tablet
Part 2 - Arm 1	Active comparator	ezetimibe/simvastatin combination tablet + niacin (ER) Receives: Drug: Comparator: ezetimibe/simvastatin and niacin (ER)
Part 2 - Arm 2	Placebo comparator	ezetimibe/simvastatin combination tablet + niacin (Pbo) Receives: Drug: Comparator: ezetimibe and simvastatin; Drug: Comparator: Placebo to niacin (ER)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline
Measured: Baseline and 24 Weeks
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline
Measured: Baseline and 24 weeks

Secondary outcomes (8)

Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
Measured: Baseline and 24 weeks
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline
Measured: Baseline and 24 weeks
Percent Change From Baseline in Triglycerides (TG)
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline
Measured: baseline and 24 Weeks
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline
Measured: Baseline and 64 weeks
Percent Change From Baseline in Triglycerides (TG)
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline
Measured: Baseline and 64 weeks
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline
Measured: Baseline and 64 weeks
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline
Measured: Baseline and 64 weeks
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline
Measured: Baseline and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2005Feb 2008

First posted4 Jan 2006 (estimated)
Study startDec 2005
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies 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
Who is masked: Participant, Investigator
Enrolment: 1,220 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00271817
Sponsor's protocol ID: 0653A-091
Other IDs: 2005_091
Status last verified: Feb 2022
First submitted: 3 Jan 2006
Last updated: 16 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Guyton JR, Brown BG, Fazio S, Polis A, Tomassini JE, Tershakovec AM. Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. J Am Coll Cardiol. 2008 Apr 22;51(16):1564-72. doi: 10.1016/j.jacc.2008.03.003.
PubMed 18420099
Le NA, Jin R, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Changes in lipoprotein particle number with ezetimibe/simvastatin coadministered with extended-release niacin in hyperlipidemic patients. J Am Heart Assoc. 2013 Aug 7;2(4):e000037. doi: 10.1161/JAHA.113.000037.
PubMed 23926117
Guyton JR, Fazio S, Adewale AJ, Jensen E, Tomassini JE, Shah A, Tershakovec AM. Effect of extended-release niacin on new-onset diabetes among hyperlipidemic patients treated with ezetimibe/simvastatin in a randomized controlled trial. Diabetes Care. 2012 Apr;35(4):857-60. doi: 10.2337/dc11-1369. Epub 2012 Feb 14.
PubMed 22338103

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia
ClinicalTrials.gov ID: NCT00271817
Acronym / sponsor ID: 0653A-091
Conditions: Hypercholesterolemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,220 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 4 Jan 2006 (estimated)
Results: Posted 3 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Part 1 - Arm 1	Active comparator	Drug: Comparator: ezetimibe/simvastatin + niacin (ER)ezetimibe/simvastatin combination tablet + niacin (ER)
Part 1 -Arm 2	Active comparator	Drug: Comparator: ezetimibe (+) simvastatin, Drug: Comparator: Placebo to Niacin (ER)ezetimibe/simvastatin
Part 1 - Arm 3	Active comparator	Drug: Comparator: Placebo to ezetimibe/simvastatin, Drug: Comparator: niacin (ER) tabletNiacin (ER)
Part 2 - Arm 1	Active comparator	Drug: Comparator: ezetimibe/simvastatin and niacin (ER)ezetimibe/simvastatin combination tablet + niacin (ER)
Part 2 - Arm 2	Placebo comparator	Drug: Comparator: ezetimibe and simvastatin, Drug: Comparator: Placebo to niacin (ER)ezetimibe/simvastatin combination tablet + niacin (Pbo)

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
Patient willing to be on a low-cholesterol diet

Key exclusion criteria (4 listed)

Pregnant or lactating women or intending to become pregnant
Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk

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
Comparator: ezetimibe/simvastatin + niacin (ER)ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks	Drug	Part 1 - Arm 1
Comparator: Placebo to ezetimibe/simvastatinezetimibe/simvastatin (Pbo) tablet. Treatment time will be ~24 weeks.	Drug	Part 1 - Arm 3
Comparator: niacin (ER) tabletniacin (ER) tablet, titrating to 2g, po qd. Treatment time will be ~24 weeks	Drug	Part 1 - Arm 3
Comparator: ezetimibe (+) simvastatinezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~24 weeks.	Drug	Part 1 -Arm 2
Comparator: Placebo to Niacin (ER)Niacin (ER) (Pbo) tablet. Treatment time will be ~24 weeks.	Drug	Part 1 -Arm 2
Comparator: ezetimibe/simvastatin and niacin (ER)ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be ~40 additional weeks for a total of 64 weeks	Drug	Part 2 - Arm 1
Comparator: ezetimibe and simvastatinezetimibe/simvastatin 10/20mg tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks	Drug	Part 2 - Arm 2
Comparator: Placebo to niacin (ER)Niacin (ER) (Pbo) tablet. Treatment time will be ~40 additional weeks for a total of 64 weeks	Drug	Part 2 - Arm 2

Primary outcome

Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline and 24 Weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline and 24 weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline

8 secondary outcomes

Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Time frame: Baseline and 24 weeks
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
Time frame: Baseline and 24 weeks
Percent Change From Baseline in Triglycerides (TG)
Time frame: baseline and 24 Weeks
Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
Time frame: Baseline and 64 weeks
Percent Change From Baseline in Triglycerides (TG)
Time frame: Baseline and 64 weeks
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Time frame: Baseline and 64 weeks
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline and 64 weeks
Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Time frame: Baseline and 24 weeks

Results and safety

Results posted to the registry on 3 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Niacin	272	166
Ezetimibe/Simvastatin	272	213
Ezetimibe/Simvastatin + Niacin	676	391

Primary outcome: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

Time frame: Baseline and 24 Weeks. Mean (Standard Error). Unit: Percent change

Measure	Niacin n = 166	Ezetimibe/Simvastatin + Niacin n = 391
Value	-20.1 (1.3)	-58.5 (0.8)

Niacin vs Ezetimibe/Simvastatin + Niacin: Mean Difference (Final Values): -38.4 (95% CI -41.4 to -35.4), p <0.001, ANCOVA

Population analysed: The participant population for this analysis is the Completers Population. This includes all patients with a baseline value, who receive at least 24 weeks of active study therapy, and who have an on-treatment measurement at the maximum titrated dose per the protocol.

Primary outcome: Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

Time frame: Baseline and 24 weeks. Mean (Standard Error). Unit: Percent change

Measure	Ezetimibe/Simvastatin n = 212	Ezetimibe/Simvastatin + Niacin n = 391
Value	-53.5 (1.2)	-58.5 (0.8)

Ezetimibe/Simvastatin vs Ezetimibe/Simvastatin + Niacin: Mean Difference (Final Values): -4.9 (95% CI -7.7 to -2.1), p <0.001, ANCOVA

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Niacin	8 of ?	121 of ?	Not reported
Ezetimibe/Simvastatin	13 of ?	428 of ?	Not reported
Ezetimibe/Simvastatin + Niacin	16 of ?	185 of ?	Not reported
Ezetimibe/Simvastatin - Part 2	29 of ?	175 of ?	Not reported
Ezetimibe/Simvastatin + Niacin - Part 2	59 of ?	505 of ?	Not reported

Limitations and caveats (from the sponsor): Part 1 population is all patients enrolled in Part 1 of the study. Part 2 is those patients who received either niacin, ezetimibe/simvastatin, or ezetimibe/simvastatin + niacin during Part 1 until they finished the study at week 64 or discontinued.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18420099Guyton JR, Brown BG, Fazio S, Polis A, Tomassini JE, Tershakovec AM. Lipid-altering efficacy and safety of ezetimibe/simvastatin coadministered with extended-release niacin in patients with type IIa or type IIb hyperlipidemia. J Am Coll Cardiol. 2008 Apr 22;51(16):1564-72. doi: 10.1016/j.jacc.2008.03.003.
Derived from this study: PubMed 23926117Le NA, Jin R, Tomassini JE, Tershakovec AM, Neff DR, Wilson PW. Changes in lipoprotein particle number with ezetimibe/simvastatin coadministered with extended-release niacin in hyperlipidemic patients. J Am Heart Assoc. 2013 Aug 7;2(4):e000037. doi: 10.1161/JAHA.113.000037.
Derived from this study: PubMed 22338103Guyton JR, Fazio S, Adewale AJ, Jensen E, Tomassini JE, Shah A, Tershakovec AM. Effect of extended-release niacin on new-onset diabetes among hyperlipidemic patients treated with ezetimibe/simvastatin in a randomized controlled trial. Diabetes Care. 2012 Apr;35(4):857-60. doi: 10.2337/dc11-1369. Epub 2012 Feb 14.
Individual participant dataSharing planned: No

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

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 4 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 16 May 2024. 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. 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 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?

Yes. Results are posted in the registry (first posted 3 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (time frame: Baseline and 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00271817, which also lists 3 linked publications.

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 16 May 2024.