HypercholesterolemiaPhase 3GRAVITYNCT00525824

12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

A Phase 3 study testing Rosuvastatin (Crestor), Ezetimibe and Simvastatin in people with Hypercholesterolemia and Coronary Heart Disease, run by AstraZeneca at 9 sites in 9 countries.

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

The purpose of this study is to determine whether treatment of Rosuvastatin (CRESTOR™) or Simvastatin given as monotherapy or given in combination with Ezetimibe, will lower the Low Density Lipoprotein Cholesterol (LDL-C) in patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis
What is being tested?: Rosuvastatin (Crestor), Ezetimibe and Simvastatin
How many people: 1,743 participants
Where: 9 sitesin 9 countries
Study dates: Aug 2007to Sep 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of >20
Patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies.
Patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. Dietary counselling will be provided which will include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will be asked to follow

Who cannot join

Use of lipid lowering drugs and other prohibited concomitant medications. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe.
Patients considered to be unstable by their physician after the following events:
a myocardial infarction, recent episode of unstable angina, myocardial revascularisation [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or stroke and patients awaiting a planned myocardial revascularisation

Trial locations and contacts

9 sites in 9 countries.

Country

City, postcode or hospital

9 sites in 9 countries

United States1 site

Research Site
Brentwood, Tennessee

Other trials in United States

Argentina1 site

Research Site
Buenos Aires

Other trials in Argentina

Brazil1 site

Research Site
São Paulo, São Paulo

Other trials in Brazil

Chile1 site

Research Site
Santiago

Other trials in Chile

Colombia1 site

Research Site
Brentwood

Other trials in Colombia

Lithuania1 site

Research Site
Brentwood

Other trials in Lithuania

Netherlands1 site

Research Site
Zwinderen

Other trials in Netherlands

Peru1 site

Research Site
Lima, San Isidro Lima

Other trials in Peru

Venezuela1 site

Research Site
Brentwood

Other trials in Venezuela

About this study

Official title: A 12-week Open-label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to Compare the Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe and Simvastatin in Patients With Hypercholesterolaemia and CHD

Conditions: Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis
Being tested: Rosuvastatin (Crestor), Ezetimibe, Simvastatin
Keywords: Hypercholesterolaemia, Coronary Heart Disease (CHD), Atherosclerosis
Medical subject headings: Hypercholesterolemia, Coronary Disease, Atherosclerosis

What participants receive

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

Rosuvastatin (Crestor)Drug
10mg and 20 mg
EzetimibeDrug
10 mg
SimvastatinDrug
40mg and 80 mg

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) After 6 Weeks Combination Treatment
Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)

Secondary outcomes (12)

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment
Percent change in HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
Percent change in TC = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
Percent change in TG = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment
Percent change in nonHDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment
Percent change in ApoB = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment
Percent change in ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in TC/HDL-C After 6 Weeks Combination Treatment
Percent change in TC/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment
Percent change in LDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment
Percent change in non-HDL-C/HDL-C = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment
Percent change in ApoB/ApoA-1 = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment
Percent change in hs-CRP = (Combination treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in LDL-C After 6 Weeks Monotherapy
Percent change in LDL-C = (Monotherapy treatment value - Baseline value)/Baseline value*100
Measured: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)

Timeline

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

Aug 2007Sep 2008

First posted6 Sep 2007 (estimated)
Study startAug 2007
Primary completionSep 2008
Study completionSep 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.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,743 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00525824
Sponsor's protocol ID: D356FC00003
Acronym: GRAVITY
Status last verified: May 2011
First submitted: 5 Sep 2007
Last updated: 13 May 2011
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-week Open-label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to Compare the Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe and Simvastatin in Patients With Hypercholesterolaemia and CHD
ClinicalTrials.gov ID: NCT00525824
Acronym / sponsor ID: GRAVITY / D356FC00003
Conditions: Hypercholesterolemia, Coronary Heart Disease, Atherosclerosis
Keywords: Hypercholesterolaemia, Coronary Heart Disease (CHD), Atherosclerosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,743 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 6 Sep 2007 (estimated)
Results: Posted 7 Oct 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)

Who may qualify

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

Key inclusion criteria (3 listed)

Patients with with hypercholesterolaemia and CHD or a CHD risk equivalent, clinical evidence of atherosclerosis or a Framingham 10-year CHD risk score of >20
Patients will need to sign an informed consent before any visit procedures can be performed, including procedures for the optional genetic research and biomarker studies.
Patients must be 18 years or older and will be asked to stop taking any current cholesterol-lowering medications. Dietary counselling will be provided which will include an overview of the Therapeutic Lifestyle Change (TLC) diet the patients will be asked to follow

Key exclusion criteria (3 listed)

Use of lipid lowering drugs and other prohibited concomitant medications. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe.
Patients considered to be unstable by their physician after the following events:
a myocardial infarction, recent episode of unstable angina, myocardial revascularisation [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or stroke and patients awaiting a planned myocardial revascularisation

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
Rosuvastatin (Crestor)10mg and 20 mg	Drug	–
Ezetimibe10 mg	Drug	–
Simvastatin40mg and 80 mg	Drug	–

Primary outcome

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent change in LDL-C = (Combination treatment value - Baseline value)/Baseline value*100

12 secondary outcomes

Percent Change in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Total Cholesterol (TC) After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Triglycerides (TG) After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Non-high-density Lipoprotein Cholesterol (nonHDL-C) After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Apolipoprotein B (ApoB) After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Apolipoprotein A1 (ApoA-1) After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in TC/HDL-C After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in LDL-C/HDL-C After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in Non-HDL-C/HDL-C After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in ApoB/ApoA-1 After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) After 6 Weeks Combination Treatment
Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)
Percent Change in LDL-C After 6 Weeks Monotherapy
Time frame: Mean of Weeks 4 and 6 on monotherapy (Last observation carried forward)

Results and safety

Results posted to the registry on 7 Oct 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
R10 to R10 + E10	214	195
R20 to R20 + E10	214	186
S40 to S40 + E10	202	183
S80 to S80 + E10	203	188

Primary outcome: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks Combination Treatment

Time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward). Mean (Standard Deviation). Unit: Percentage

Measure	R10 to R10 + E10 n = 210	R20 to R20 + E10 n = 204	S40 to S40 + E10 n = 199	S80 to S80 + E10 n = 201
Value	-59.7200 (14.1660)	-63.4800 (16.6970)	-55.2200 (15.7500)	-57.4200 (20.4660)

12 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
Rosuvastatin 10 mg	3 of ?	25 of ?	Not reported
Rosuvastatin 20 mg	5 of ?	31 of ?	Not reported
Simvastatin 40 mg	1 of ?	28 of ?	Not reported
Simvastatin 80 mg	3 of ?	26 of ?	Not reported
Rosu 10 mg + Eze 10 mg	4 of ?	18 of ?	Not reported
Rosu 20 mg + Eze 10 mg	1 of ?	23 of ?	Not reported
Simva 40 mg + Eze 10 mg	7 of ?	24 of ?	Not reported
Simva 80 mg + Eze 10 mg	4 of ?	21 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypercholesterolemia

Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous 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.

Christie M Ballantyne, MD FACP FACC principal investigator

Centre for Cardiovascular Disease Prevention

Margareta Grind, MD PhD FFPM study chair

Medicine and Sciences AstraZeneca

9 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosuvastatin (Crestor), Ezetimibe and Simvastatin in people with Hypercholesterolemia and Coronary Heart Disease, run by AstraZeneca at 9 sites in 9 countries.

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 3 inclusion and 3 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 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Argentina, Brazil, Chile, Colombia and 4 more countries. 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 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 7 Oct 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) After 6 Weeks Combination Treatment (time frame: Mean of Weeks 4 and 6 on combination therapy (Last observation carried forward)). 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 NCT00525824.

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 13 May 2011.