Clinical Trials Register

Summary
EudraCT Number:	2006-003107-39
Sponsor's Protocol Code Number:	023-00
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-07-12
Trial results	View 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

Italy - Italian Medicines Agency

A.2

EudraCT number

2006-003107-39

A.3

Full title of the trial

a worldwide, multicenter, ouble-blind, randomized, parallel study to evaluate the efficacy of MK 0524 to improve tolerability of extended release niacin

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

023-00

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

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	MERCK SHARP DOHME
B.1.3.4	Country	Italy
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	No
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.3.1	Product name	mk 524 A
D.3.2	Product code	mk 524 a
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.3.9.2	Current sponsor code	mk 524 A
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	40
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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	No
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.3.1	Product name	mk 524 A
D.3.2	Product code	mk 524 a
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.3.9.2	Current sponsor code	mk 524 A
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	40
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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: 3
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	No
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.3.1	Product name	mk 524 A
D.3.2	Product code	mk 524 a
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.3.9.2	Current sponsor code	mk 524 A
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	40
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
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

hypercholesterolemia

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	SOC
E.1.2	Classification code	10014698
E.1.2	Term	Endocrine disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Obiettivi: dimostrare l'efficacia di MK-0524 nel proteggere dall'insorgenza del ﾓflushingﾔ indotto dalla niacina in pazienti che riassumono la terapia o con MK-0524A 2g o niacina a rilascio prolungato 2g, dopo un periodo di 5 giorni in cui i pazienti non assumono la terapia, preceduto da un periodo di dose stabile di MK-0524A 2g.

Ipotesi: MK-0524A 2g produce minor ﾓflushingﾔ rispetto a niacina a rilascio prolungato 2 g durante i primi 7 giorni che seguono il periodo di interruzione della terapia di 5 giorni; il ﾓflushingﾔ e' misurato con il massimo punteggio, Global Flushing Symptom Score (GFSS), assegnato dai pazienti con la compilazione del questionario tramite i diari elettronici; il ﾓflushingﾔ sara' classificato in nessuno/lieve, moderato, grave ed estremo.

E.2.2

Secondary objectives of the trial

1) Obiettivo: dimostrare l'efficacia di MK-0524 nel proteggere dall'insorgenza del ﾓflushingﾔ indotto dalla niacina in pazienti che riassumono la terapia o con MK-0524A 2g o niacina a rilascio prolungato 2g, dopo un periodo di 5 giorni in cui i pazienti non assumono la terapia, preceduto da un periodo di dose stabile di MK-0524A 2g.

a. Ipotesi: MK-0524A 2g produce minor ﾓflushingﾔ rispetto a niacina a rilascio prolungato 2 g durante i primi 7 giorni che seguono il periodo di interruzione della terapia di 5 giorni; il ﾓflushingﾔ e' misurato con il massimo punteggio, Global Flushing Symptom Score (GFSS).

b. Ipotesi: MK-0524A 2g produce minor ﾓflushingﾔ rispetto a niacina a rilascio prolungato 2 g durante i primi 7 giorni che seguono il periodo di interruzione della terapia di 5 giorni; il ﾓflushingﾔ e' misurato con la percentuale di pazienti che assegnano un punteggio Global Flushing Symptom Score (GFSS) > 4, corrispondente a ﾓflushingﾔ moderato o piu' intenso.

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

1. Paziente di sesso maschile o femminile di eta' >=18 e <=70 anni al momento di firma del consenso informato.

2. Paziente in grado di comprendere le procedure dello studio, i possibili trattamenti alternativi, i rischi possibili, e che accetta volontariamente di partecipare dando il consenso informato scritto.

3. Contraccezione per donne in eta' fertile: donne in eta' fertile debbono accettare di utilizzare 2 metodi di controllo delle nascite o di astenersi da rapporti sessuali per l'intera durata dello studio. I metodi di controllo delle nascite utilizzati debbono essere tra questi elencati: spirale (IUD), diaframma con spermicida, spugna contraccettiva, preservativo, vasectomia.

Nota: Donne in menopausa, o che hanno avuto isterectomia oppure ovariectomia o la legatura tubale bilaterale sono eleggibili senza l'utilizzo di contraccettivi.

E.4

Principal exclusion criteria

1. Paziente e' in gravidanza o nel periodo di allattamento, o che ha programmato una gravidanza durante lo studio incluso il periodo di follow-up di 14 giorni successivi al termine dello studio.

2. Paziente che ha avuto un tumore maligno nei 5 anni precedenti a partire dalla firma del consenso informato, ad eccezione di basalioma o cancro epidermoide o cancro del collo dell'utero localizzato, che siano stati adeguatamente curati.

Nota: Pazienti che hanno avuto un tumore maligno nei 5 anni precedenti possono essere inclusi nello studio se, secondo il Ricercatore e lo Sponsor, una recidiva sia altamente improbabile durante lo studio.

3. Paziente che ha avuto o che abbia qualsiasi condizione o valori anormali di laboratorio o assuma una terapia che possano interferire con i risultati dello studio o con la partecipazione del paziente per l'intera durata dello studio, o che rendano non adeguata per il paziente la partecipazione allo studio.

4. Paziente che consuma piu' di 2 bicchieri di bevande alcooliche al giorno.

5. Paziente che si ritiene non adatto a seguire le procedure dello studio, a mantenere gli appuntamenti o che ha programmato di trasferirsi durante lo studio.

6. Paziente che sta partecipando o che ha partecipato ad uno studio clinico con un farmaco sperimentale che non abbia effetti su assetto lipidico nei precedenti 30 giorni da Visita 1

7. Paziente donatore o che ha ricevuto sangue, come di seguito descritto:

nelle 8 settimane precedenti la firma del consenso informato piu' di 300 mL di sangue donato o ricevuto o perso in seguito a flebotomia.

paziente che intenda donare o ricevere sangue durante lo studio.

paziente che intenda donare piu' di 250 mL di sangue nelle 8 settimane successive all'ultima visita dello studio.

8. Paziente che risulta avere alla Visita 1 i seguenti valori di laboratorio dalle analisi eseguite dal laboratorio centralizzato:

Creatinina >2.0 mg/dL (177 micromol/L),

ALT (SGPT) >1.5 volte il valore superiore dell'intervallo normale di laboratorio.

AST (SGOT) >1.5 volte il valore superiore dell'intervallo normale di laboratorio.

CK >2 volte il valore superiore dell'intervallo normale di laboratorio.

9. Paziente che consuma sostanze illecite o ha avuto storia recente (nell'anno precedente, dalla firma del consenso informato) di abuso di droghe o di alcool.

E.5 End points

E.5.1

Primary end point(s)

dimostrare l'efficacia di MK-0524 nel proteggere dall'insorgenza del ﾓflushingﾔ indotto dalla niacina in pazienti che riassumono la terapia o con MK-0524A 2g o niacina a rilascio prolungato 2g, dopo un periodo di 5 giorni in cui i pazienti non assumono la terapia, preceduto da un periodo di dose stabile di MK-0524A 2g.

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Information not present in EudraCT

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

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

Yes

E.8.5

The trial involves multiple Member States

Yes

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

Information not present in EudraCT

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
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	Information not present in EudraCT
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 2007-07-12.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
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	60
F.4.2	For a multinational trial
F.4.2.1	In the EEA	270
F.4.2.2	In the whole clinical trial	825

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

2006-07-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-10-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-08-18

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