Clinical Trials Register

Summary
EudraCT Number:	2006-003544-27
Sponsor's Protocol Code Number:	PRV-06009
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2006-07-05
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2006-003544-27

A.3

Full title of the trial

An Evaluation of Simvastatin 20 mg Plus Omacor 4 g Compared to Simvastatin 20 mg Plus Placebo in Subjects with Mixed Dyslipidemia

A.4.1

Sponsor's protocol code number

PRV-06009

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Provident Clinical Research & Consulting, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Omacor
D.2.1.1.2	Name of the Marketing Authorisation holder	Reliant Pharmaceuticals, Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	25378272
D.3.9.3	Other descriptive name	EICOSAPENTAENOIC ACID
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1860
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	8000046937
D.3.9.3	Other descriptive name	DOCOSAHEXANOIC ACID
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Zocor
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SIMVASTATIN
D.3.9.1	CAS number	79902639
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, soft
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

mixed dyslipidemia

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	8.1
E.1.2	Level	LLT
E.1.2	Classification code	10058110
E.1.2	Term	Dyslipidemia

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this clinical trial is to evaluate the effect of Simvastatin 20 mg/d plus Omacor 4 g/d compared to Simvastatin 20 mg/d plus placebo on the percent change from baseline in non-HDL-C

E.2.2

Secondary objectives of the trial

The secondary objectives of this clinical trial are to evaluate the effect of Simvastatin 20 mg/d plus Omacor 4 g/d compared to Simvastatin 20 mg/d plus placebo on the percent change from baseline in LDL-C, TG, TC, VLDL-C, HDL-C, TC:HDL-C and TG:HDL-C ratios and Apo A1 and B.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Men and women ages 18-79 years, inclusive.
2. LDL-C above ATP III goal (average of weeks -2 and -1 values) after discontinuation of any lipid-altering therapies at visit 1 (week -5).
3. Fasting TG value 200 to 600 mg/dL, inclusive (average of values obtained at weeks -2 and -1), after discontinuation of any lipid-altering therapies at visit 1 (week -5).
4. Willing to maintain the Therapeutic Lifestyle Changes (TLC) diet and current physical activity level throughout the trial.
5. If a smoker, the subject has no plans to change smoking habits during the study period.
6. Women who have had a hysterectomy, tubal ligation or who are post-menopausal for at least one year prior to the study may be enrolled. Women of childbearing potential who are not pregnant, not planning to become pregnant during the study period, and not lactating may be enrolled if they are using a medically acceptable contraceptive program initiated at least two months prior to study entry and continued during the study.

E.4

Principal exclusion criteria

1. Use after Visit 1 (screening) and during the treatment period of any non-study- lipid-altering drugs, including statins, bile acid sequestrants, cholesterol absorption inhibitors, or fibrates.
2. Use after Visit 1 (screening) and during the treatment period of any non-study-related omega-3 fatty acid supplements (e.g., flaxseed, fish, or algal oils) or enriched foods (consumption of up to two servings per week of fish is acceptable).
3. Use after Visit 1 (screening) and during the treatment period of any supplement known to alter lipid metabolism, including but not limited to: sterol/stanol products; dietary fiber supplements (including >2 teaspoons Metamucil or psyllium-containing supplement per day); red rice yeast supplements; garlic supplements; soy isoflavone supplements; niacin or its analogues at doses >200 mg/d (or others at the discretion of the investigator).
4. History of a cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure in the six months prior to Visit 1 (screening).
5. BMI >40.0 kg/m2
6. Presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to Visit 1 (screening).
7. Poorly controlled diabetes mellitus (HbA1C >9.0% at Visit 1) or diabetes mellitus requiring insulin therapy.
8. Known lipoprotein lipase impairment or deficiency or apo C-II deficiency or familial dysbetalipoproteinemia. (Type III hyperlipidemia).
9. History of pancreatitis.
10. History of allergy or sensitivity to statins [or any other hydroxymethylglutaryl Coenzyme A (HMG-CoA) reductase inhibitors], omega-3 fatty acids (or any other lipid-regulating agents) or fish.
11. Concomitant use of cyclosporine, itraconazole, ketoconazole, erythromycin, azithromycin, clarithromycin, human immunodeficiency virus (HIV) protease inhibitors, amiodarone, verapamil, telithromycin, digoxin, nefazodone, warfarin, or danazol.
12. Oral or systemic use of corticosteroids, or topical, inhaled, intranasal or dermal use of more than 1500 micrograms (µg) daily.
13. Concomitant use of phenytoin.
14. Chronic use of androgens.
15. Use of cyclic sex hormone therapy or cyclic oral contraceptives within 2 months of Visit 1 (screening) or during the study.
16. Unstable use (less than two months prior to visit 1) of medications for hypertension, diabetes mellitus, or hypothyroidism.
17. Use after Visit 1 (screening) of weight loss drugs (including over-the-counter) or programs during the trial.
18. Current symptoms of unexplained muscle pain, tenderness or weakness (i.e., signs indicative of possible myopathy), or any diagnosis of myopathy or rhabdomyolysis.
19. Serum transaminase(s) (aspartate aminotransferase or alanine aminotransferase) levels >1.5 x upper limits of normal (ULN) at Visit 1 (screening).
20. Serum creatinine level ≥2.0 mg/dL at Visit 1 (screening).
21. Poorly controlled hypertension, defined as resting blood pressure ≥160 mm Hg systolic and/or ≥100 mm Hg diastolic at two consecutive visits prior to visit 4.
22. Current or recent history (past 12 months) of drug or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week.
23. Participation in another clinical trial or exposure to any investigational agent within 30 days prior to Visit 1 (screening).
24. Recent history (within six months) or current significant renal, pulmonary, hepatic, biliary, or gastrointestinal disease.
25. History of cancer (except non-melanoma skin cancer) within the previous 2 years.
26. Individual has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.

E.5 End points

E.5.1

Primary end point(s)

The primary outcome variable will be the percent change from baseline in non-HDL-C. Baseline will be considered the average of values collected at weeks -2, -1 and 0. On-treatment values will be average of values collected at weeks 5 and 6 for period 1, and the average of values collected at weeks 11 and 12 for period 2.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Information not present in EudraCT

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-07-05.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	16
F.4.2	For a multinational trial
F.4.2.1	In the EEA	16
F.4.2.2	In the whole clinical trial	30

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2006-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-07-21

P. End of Trial
P.	End of Trial Status	Ongoing

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