DyslipidemiaPhase 3NCT01674712

A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease

A Phase 3 study testing Fixed Combination of Fenofibrate/simvastatin 145/20 mg, Simvastatin 20 mg and Fenofibrate 145 mg in people with Dyslipidemia, run by Abbott at 69 sites in 7 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

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Dyslipidemia
What is being tested?: Fixed Combination of Fenofibrate/simvastatin 145/20 mg, Simvastatin 20 mg and Fenofibrate 145 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 575 participants
Where: 69 sitesin 7 countries
Study dates: Jun 2012to Oct 2013
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.
between 18 (inclusive) and 80 years
With mixed dyslipidemia with fasting lipid results of a blood sample taken at inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):
TG higher than/equal to 1.71 mmol/L (higher than/equal to 150 mg/dL) and
LDL-C higher or equal to 1.81 mmol/L (higher or equal 70 mg/dL) but smaller than/equal to 3.36 mmol/L (smaller than/equal to 130 mg/dL)
High risk or very high risk based on known CardioVascular Disease (CVD) or type 2 diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary Risk Estimation (SCORE) chart risk ≥ 5percent
Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2 times the Upper Normal of Limit (UNL)

Who cannot join

Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,
Pregnant or lactating women,
Unable or unwilling to comply with the protocol and the recommended diet,
Likely to withdraw from the study before its completion,
Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1

Trial locations and contacts

69 sites in 7 countries.

Country

City, postcode or hospital

69 sites in 7 countries

Argentina15 sites

Site Reference ID/Investigator# 77961
Buenos Aires, 7600
Site Reference ID/Investigator# 77957
Buenos Aires, B1605DSX
Site Reference ID/Investigator# 77958
Buenos Aires, B1657BHD
Site Reference ID/Investigator# 77960
Buenos Aires, B1722COV
Site Reference ID/Investigator# 77959
Buenos Aires, B1878GEG
Site Reference ID/Investigator# 77969
Buenos Aires, B2800DGH
Site Reference ID/Investigator# 77967
Buenos Aires, C1179AAB
Site Reference ID/Investigator# 77968
Buenos Aires, C1181ACK
Site Reference ID/Investigator# 77965
Buenos Aires, C1405BCH
Site Reference ID/Investigator# 77956
Buenos Aires
Site Reference ID/Investigator# 77966
Cipolletti - Rio Negro, 8324
Site Reference ID/Investigator# 77963
San Miguel de Tucumán, 4000JCU
Site Reference ID/Investigator# 77955
Santa Fe, 3000
Site Reference ID/Investigator# 77962
Santa Fe, 3000
Site Reference ID/Investigator# 77964
Santa Fe, S2000DSV

Other trials in Argentina

Germany14 sites

Site reference ID/Investigator # 97356
Berlin, 10117
Site Reference ID/Investigator# 90673
Berlin, 10249
Site Reference ID/Investigator# 80100
Berlin, 12351
Site reference ID/Investigator # 97357
Berlin, 13125
Site reference ID/Investigator # 102016
Cologne, 51069
Site reference ID/Investigator # 102017
Dortmund, 44137
Site reference ID/Investigator # 99876
Dresden, 01069
Site Reference ID/Investigator# 80102
Düsseldorf, 40597
Site Reference ID/Investigator# 80104
Essen, 45355
Site Reference ID/Investigator# 80103
Essen, 45359
Site Reference ID/Investigator# 80105
Frankfurt, 60594
Site Reference ID/Investigator# 80101
Goch, 47574
Site reference ID/Investigator # 99902
Hamburg, 20253
Site reference ID/Investigator # 102015
Karlsruhe, 76199

Other trials in Germany

Russia13 sites

Site Reference ID/Investigator# 80120
Kemerovo, 650002
Site Reference ID/Investigator# 80135
Moscow, 119435
Site Reference ID/Investigator# 80137
Moscow, 119620
Site Reference ID/Investigator# 80124
Moscow, 119991
Site Reference ID/Investigator# 80127
Moscow, 125284
Site Reference ID/Investigator# 80122
Novosibirsk, 630008
Site Reference ID/Investigator# 80121
Novosibirsk, 630047
Site Reference ID/Investigator# 80133
Novosibirsk, 630068
Site reference ID/Investigator # 80134
Saint Petersburg, 194156
Site reference ID/Investigator # 80126
Saint Petersburg, 197022
Site reference ID/Investigator # 80128
Saint Petersburg, 197022
Site Reference ID/Investigator# 80136
Saint Petersburg, 199106
Site Reference ID/Investigator# 80125
Yaroslavl, 150010

Other trials in Russia

Czechia9 sites

Site reference ID/Investigator # 99617
Benátky nad Jizerou, 294 71
Site Reference ID/Investigator# 80097
Brno, 656 91
Site reference ID/Investigator # 102335
Brno, 65691
Site Reference ID/Investigator# 80094
Prague, 108 00
Site Reference ID/Investigator# 80095
Prague, 14059
Site Reference ID/Investigator# 80093
Prague, 18081
Site Reference ID/Investigator# 80098
Teplice, 415 01
Site Reference ID/Investigator# 80096
Ústí nad Labem, 40113
Site Reference ID/Investigator# 80099
Znojmo, 669 02

Other trials in Czechia

Poland7 sites

Site Reference ID/Investigator# 80111
Gdansk, 80-952
Site Reference ID/Investigator# 80112
Gdansk, 80-952
Site Reference ID/Investigator# 80110
Gdynia, 81-423
Site Reference ID/Investigator# 80106
Katowice, 40-954
Site Reference ID/Investigator# 80109
Płock, 09-400
Site Reference ID/Investigator# 80108
Skierniewice, 96-100
Site Reference ID/Investigator# 80107
Warsaw, 01-868

Other trials in Poland

Romania7 sites

Site reference ID/Investigator # 80115
Bucharest, 10242
Site Reference ID/Investigator# 80114
Bucharest, 11172
Site Reference ID/Investigator# 80117
Bucharest, 11794
Site Reference ID/Investigator# 80116
Bucharest, 20054
Site Reference ID/Investigator# 80119
Bucharest, 22328
Site Reference ID/Investigator# 80113
Bucharest, 42122
Site Reference ID/Investigator# 80118
Iași, 700547

Other trials in Romania

Mexico4 sites

Site Reference ID/Investigator# 77970
Guadalajara, Jal., C.P. 44130
Site Reference ID/Investigator# 77973
Mexico City, C.P. 06600
Site Reference ID/Investigator# 77972
Mexico City, C.P. 11850
Site Reference ID/Investigator# 77974
Zapopan, 45200

Other trials in Mexico

About this study

Official title: A 12-week, Double-blind, Randomized Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate / Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets vs. Matching Monotherapies in Dyslipidemic Subjects at High Risk of Cardiovascular Disease.

This is a double-blind, randomized study designed to compare the efficacy and safety of two fixed combinations of fenofibrate / simvastatin 145/20 mg and fenofibrate / simvastatin 145/40 mg tablets vs. matching monotherapies in subjects with abnormal fat (lipids) in the blood and at high risk of cardiovascular disease. Fenofibrate is a treatment that lowers fat in blood. It is prescribed in patients with high levels of triglycerides (TG). The drug has been marketed in more than 80 countries since 1975. Simvastatin is also used for the treatment of patients with a high level of cholesterol. These have also been marketed worldwide for more than 20 years. It is important to treat high levels of fats in the blood because it has been shown that even mildly elevated level of lipids in the blood can lead to diseases of the blood vessels. It has been shown in several studies and in clinical practice that the combination of fenofibrate plus simvastatin can lead to improved effects on blood fats, compared to treatment with simvastatin or fenofibrate alone. The main objective of the study is to compare the efficacy of the two fixed-combinations (FC) -fenofibrate/simvastatin 145/20 mg tablet and fenofibrate/simvastatin 145/40 mg tablet in reducing TG and increasing high density lipoprotein cholesterol (HDL-C) versus simvastatin 20 mg or 40 mg, and in reducing low density lipoprotein cholesterol (LDL-C) versus fenofibrate 145 mg.

Conditions: Dyslipidemia
Being tested: Fixed Combination of Fenofibrate/simvastatin 145/20 mg, Simvastatin 20 mg, Fenofibrate 145 mg, Fixed Combination of Fenofibrate/simvastatin 145/40 mg, Simvastatin 40 mg
Keywords: Fibrates, Dyslipidemia
Medical subject headings: Dyslipidemias

What participants receive

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

Fixed Combination of Fenofibrate/simvastatin 145/20 mgDrug
Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
Simvastatin 20 mgDrug
Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
Fenofibrate 145 mgDrug
Fenofibrate, tablet, 145 mg, once daily, 12 weeks
Fixed Combination of Fenofibrate/simvastatin 145/40 mgDrug
Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
Simvastatin 40 mgDrug
simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks

Study groups in NCT01674712
Study group	Role	What they receive
Fenofibrate/simvastatin 145/20 mg	Experimental	Not described Receives: Drug: Fixed Combination of Fenofibrate/simvastatin 145/20 mg
Simvastatin 20 mg	Active comparator	Not described Receives: Drug: Simvastatin 20 mg
Fenofibrate 145 mg	Active comparator	Not described Receives: Drug: Fenofibrate 145 mg
Fenofibrate/simvastatin 145/40 mg	Experimental	Not described Receives: Drug: Fixed Combination of Fenofibrate/simvastatin 145/40 mg
Simvastatin 40 mg	Active comparator	Not described Receives: Drug: Simvastatin 40 mg

What is being measured

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

Percentage of Change of TG (Triglyceride)
Collection and measurement of blood samples.
Measured: from baseline to 12 weeks of treatment
Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)
Collection and measurement of blood samples.
Measured: from baseline to 12 weeks of treatment
Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)
Collection and measurement of blood samples.
Measured: from baseline to 12 weeks of treatment

Secondary outcomes (12)

Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline
Collection and measurement of blood samples
Measured: 12 weeks
Percentage of TC (Triglyceride) From Baseline
Collection and measurement of blood samples
Measured: 12 weeks
Percentage of Apolipoprotein AI From Baseline
Collection and measurement of blood samples
Measured: 12 weeks
Percentage of Apolipoprotein B From Baseline
Collection and measurement of blood samples
Measured: 12 weeks
Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline
Collection and measurement of blood samples
Measured: 12 weeks
Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)
Collection and measurement of blood samples
Measured: 12 weeks
Adverse Events
Collection and measurement of blood samples
Measured: 12 weeks
Creatine Kinase (CK)
Collection and measurement of blood samples
Measured: 12 weeks
Alanine Aminotransferase (ALT)
Collection and measurement of blood samples
Measured: 12 weeks
Plasma Creatinine
Collection and measurement of blood samples
Measured: 12 weeks
Total Bilirubin
Collection and measurement of blood samples
Measured: 12 weeks
Cystatin C
Collection and measurement of blood samples
Measured: 12 weeks

Timeline

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

Jun 2012Oct 2013

First posted29 Aug 2012 (estimated)
Study startJun 2012
Primary completionOct 2013
Study completionOct 2013

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 DyslipidemiaStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 575 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01674712
Sponsor's protocol ID: M13-377
Other IDs: 2011-005924-16
Status last verified: Nov 2014
First submitted: 26 Jun 2012
Last updated: 11 Dec 2014
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

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Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
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All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-week, Double-blind, Randomized Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate / Simvastatin 145/20mg and Fenofibrate / Simvastatin 145/40mg Tablets vs. Matching Monotherapies in Dyslipidemic Subjects at High Risk of Cardiovascular Disease.
ClinicalTrials.gov ID: NCT01674712
Acronym / sponsor ID: M13-377
Conditions: Dyslipidemia
Keywords: Fibrates, Dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 575 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 29 Aug 2012 (estimated)
Results: Posted 30 Oct 2014

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Fenofibrate/simvastatin 145/20 mg	Experimental	Drug: Fixed Combination of Fenofibrate/simvastatin 145/20 mg
Simvastatin 20 mg	Active comparator	Drug: Simvastatin 20 mg
Fenofibrate 145 mg	Active comparator	Drug: Fenofibrate 145 mg
Fenofibrate/simvastatin 145/40 mg	Experimental	Drug: Fixed Combination of Fenofibrate/simvastatin 145/40 mg
Simvastatin 40 mg	Active comparator	Drug: Simvastatin 40 mg

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Either gender (tentatively 50 percent females to be included and if of childbearing potential she must agree to use medically acceptable methods of contraception from the time of signing the informed consent until 7 days following administration of the last treatment or dose of study medication). Accepted contraceptive methods are implants, injectables, combined oral contraceptives, intra-uterine device or sexual abstinence.
between 18 (inclusive) and 80 years
With mixed dyslipidemia with fasting lipid results of a blood sample taken at inclusion and after at least 3 months of any statin monotherapy (excluding simvastatin 80 mg, atorvastatin 40 mg and 80 mg, rosuvastatin 20 mg and 40 mg):
High risk or very high risk based on known CardioVascular Disease (CVD) or type 2 diabetes or type 1 diabetes with microalbuminuria or a Systematic Coronary Risk Estimation (SCORE) chart risk ≥ 5percent
Aspartate aminotransferase and/or alanine aminotransferase smaller than/equal to 2 times the Upper Normal of Limit (UNL)

Key exclusion criteria (5 listed)

Known hypersensitivity to fibrates or simvastatin or known photoallergic or phototoxic reactions under treatment with fibrates or ketoprofen or known allergic reactions caused by peanuts, peanuts or arachis oil or soy lecithin, or related products,
Pregnant or lactating women,
Unable or unwilling to comply with the protocol and the recommended diet,
Likely to withdraw from the study before its completion,
Having received an investigational drug or vaccine in the last 30 days before date of inclusion, or still participating in such a trial at Visit 1

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
Fixed Combination of Fenofibrate/simvastatin 145/20 mgFenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks	Drug	Fenofibrate/simvastatin 145/20 mg
Simvastatin 20 mgSimvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks	Drug	Simvastatin 20 mg
Fenofibrate 145 mgFenofibrate, tablet, 145 mg, once daily, 12 weeks	Drug	Fenofibrate 145 mg
Fixed Combination of Fenofibrate/simvastatin 145/40 mgFenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks	Drug	Fenofibrate/simvastatin 145/40 mg
Simvastatin 40 mgsimvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks	Drug	Simvastatin 40 mg

Primary outcome

Percentage of Change of TG (Triglyceride)
Time frame: from baseline to 12 weeks of treatment
Collection and measurement of blood samples.
Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)
Time frame: from baseline to 12 weeks of treatment
Collection and measurement of blood samples.
Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)
Time frame: from baseline to 12 weeks of treatment
Collection and measurement of blood samples.

12 secondary outcomes

Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline
Time frame: 12 weeks
Percentage of TC (Triglyceride) From Baseline
Time frame: 12 weeks
Percentage of Apolipoprotein AI From Baseline
Time frame: 12 weeks
Percentage of Apolipoprotein B From Baseline
Time frame: 12 weeks
Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline
Time frame: 12 weeks
Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)
Time frame: 12 weeks
Adverse Events
Time frame: 12 weeks
Creatine Kinase (CK)
Time frame: 12 weeks
Alanine Aminotransferase (ALT)
Time frame: 12 weeks
Plasma Creatinine
Time frame: 12 weeks
Total Bilirubin
Time frame: 12 weeks
Cystatin C
Time frame: 12 weeks

Results and safety

Results posted to the registry on 30 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fenofibrate/Simvastatin 145/20 mg	114	104
Simvastatin 20 mg	117	108
Fenofibrate/Simvastatin 145/40 mg	115	106
Simvastatin 40 mg	116	108
Fenofibrate 145 mg	113	102

Primary outcome: Percentage of Change of TG (Triglyceride)

Time frame: from baseline to 12 weeks of treatment. Mean (Standard Deviation). Unit: percentage of change

Measure	Fenofibrate/Simvastatin 145/20 mg n = 96	Simvastatin 20 mg n = 102	Fenofibrate/Simvastatin 145/40 mg n = 97	Simvastatin 40 mg n = 101	Fenofibrate 145 mg n = 93
Value	-30.6 (25.8)	10.7 (48.8)	-27.3 (35.9)	-2.9 (34.3)	-21.6 (34.2)

Population analysed: The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.

Primary outcome: Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)

Time frame: from baseline to 12 weeks of treatment. Mean (Standard Deviation). Unit: percentage of change

Measure	Fenofibrate/Simvastatin 145/20 mg n = 96	Simvastatin 20 mg n = 102	Fenofibrate/Simvastatin 145/40 mg n = 97	Simvastatin 40 mg n = 101	Fenofibrate 145 mg n = 93
Value	9.0 (16.8)	0.3 (12.1)	8.8 (16.5)	2.2 (12.5)	7.6 (15.7)

Population analysed: The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.

Primary outcome: Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)

Time frame: from baseline to 12 weeks of treatment. Mean (Standard Deviation). Unit: percentage of change

Measure	Fenofibrate/Simvastatin 145/20 mg n = 96	Simvastatin 20 mg n = 102	Fenofibrate/Simvastatin 145/40 mg n = 97	Simvastatin 40 mg n = 101	Fenofibrate 145 mg n = 93
Value	1.9 (25.4)	-2.0 (24.8)	-6.1 (26.2)	-8.1 (25.8)	30.3 (35.6)

Population analysed: The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.

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
Fenofibrate/Simvastatin 145/20 mg	3 of 111 (2.7%)	8 of 111 (7.2%)	Not reported
Simvastatin 20 mg	3 of 117 (2.6%)	7 of 117 (6%)	Not reported
Fenofibrate/Simvastatin 145/40 mg	3 of 113 (2.7%)	4 of 113 (3.5%)	Not reported
Simvastatin 40 mg	1 of 115 (0.9%)	9 of 115 (7.8%)	Not reported
Fenofibrate 145 mg	3 of 112 (2.7%)	15 of 112 (13.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dyslipidemia

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
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Recruiting
Ezetimibe Utilization Early After Acute Myocardial Infarction, "EzAMI Trial"
Acute Myocardial Infarction, Dyslipidemias
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure

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.

Jean-Claude Ansquer, MD study director

Abbott

69 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fixed Combination of Fenofibrate/simvastatin 145/20 mg, Simvastatin 20 mg and Fenofibrate 145 mg in people with Dyslipidemia, run by Abbott at 69 sites in 7 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 7 inclusion and 5 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 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Argentina, Germany, Russia, Czechia, Poland and 2 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 30 Oct 2014). 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?

Percentage of Change of TG (Triglyceride) (time frame: from baseline to 12 weeks of treatment). The study lists 3 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 NCT01674712.

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 Dec 2014; AzTrials last refreshed its copy on 31 Oct 2026.