Clinical Trials Register

Summary
EudraCT Number:	2011-001023-21
Sponsor's Protocol Code Number:	DRL-17822/CD/004
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:	2011-12-28
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

2011-001023-21

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of DRL-17822 in Patients with Type II Hyperlipidemia

Studio randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, per valutare efficacia, sicurezza e tollerabilita' di DRL-17822 in pazienti con Iperlipidemia di tipo II.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study with random allocation of patients to active treatment or placebo (inactive substance) in parallel group, where the nature of assigned treatment is unknown to the study team and to the patient, designed with the purpose of evaluating efficacy, safety and tolerability of DRL-17822 in patients with Iperlipidemia Type II.

Studio con assegnazione dei pazienti in modo casuale a trattamento attivo o placebo (sostanza inattiva), in gruppi paralleli, in cui il trattamento assegnato non sara' a conoscenza del personale di studio e del paziente con lo scopo di valutare quanto efficace, sicuro e tollerabile sia DRL-17822 nei pazienti affetti da Iperlipidemia di tipo II

A.4.1

Sponsor's protocol code number

DRL-17822/CD/004

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	DR. REDDY'S LABORATORIES LIMITED
B.1.3.4	Country	India
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	DR. REDDY'S LABORATORIES LIMITED
B.4.2	Country	India
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	PHARMANET Ltd.
B.5.2	Functional name of contact point	Regulatory Operations Europe
B.5.3	Address:
B.5.3.1	Street Address	Glory Park Avenue, Building Two, Wooburn Green
B.5.3.2	Town/ city	Bucks
B.5.3.3	Post code	HP10 0DF
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 870 242 0780
B.5.5	Fax number	+44 870 242 0781
B.5.6	E-mail	regopseurope@pharmanet.com

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	DRL-17822
D.3.2	Product code	DRL-17822
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
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	898911-09-6
D.3.9.2	Current sponsor code	DRL-17822
D.3.9.3	Other descriptive name	CZ0L3
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	898911-09-6
D.3.9.2	Current sponsor code	DRL-17822
D.3.9.3	Other descriptive name	CZ0L3
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	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	898911-09-6
D.3.9.2	Current sponsor code	DRL-17822
D.3.9.3	Other descriptive name	CZ0L3
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	300
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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
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

Hyperlipidemia Type II

Iperlipidemia di Tipo II

E.1.1.1

Medical condition in easily understood language

Increase of lipids (fats) in blood

Aumento dei lipidi (grassi) nel sangue

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10045254
E.1.2	Term	Type II hyperlipidaemia
E.1.2	System Organ Class	10010331 - Congenital, familial and genetic 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

To assess the efficacy of DRL- 17822 in patients with Type II hyperlipidemia

Valutare l’efficacia di DRL-17822 in pazienti con Iperlipidemia di tipo II

E.2.2

Secondary objectives of the trial

•To evaluate the safety and tolerability of DRL- 17822 in patients with Type II hyperlipidemia •To evaluate changes in vital signs including blood pressure in this population •To measure trough levels of DRL- 17822 in plasma •To evaluate changes in CETP inhibition in the plasma with DRL-17822 •To evaluate changes in lipids and apolipoproteins Exploratory: •To measure serum aldosterone and cortisol levels

• Valutare la sicurezza e tollerabilità di DRL-17822 in pazienti con Iperlipidemia di tipo II • Valutare i cambiamenti nei segni vitali, compresa la pressione sanguigna, in questa popolazione • Misurare i livelli minimi di DRL-17822 nel plasma • Valutare i cambiamenti nell’ inibizione della CETP (Cholesteryl Ester Transfer Protein) in presenza di DRL-17822 nel plasma • Valutare i cambiamenti nei lipidi e nelle apolipoproteine • Misurare i livelli di aldosterone e cortisolo nel siero

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients with Type II hyperlipidaemia having lipid values as indicated below: - HDL-C: males ≤44 mg/dL (≤1.13 mmol/L), females ≤54 mg/dL (≤1.39 mmol/L); - LDL-C: ≥130 mg/dL (≥3.33 mmol/L); 2. Male or female, 18 to 70 years of age, inclusive. Female patients must be post-menopausal or surgically sterile. Post-menopausal is defined as being amenorrhoeic for at least 24 consecutive months and a follicle stimulating hormone (FSH) level ≥30 IU/L; Men, unless surgically sterile, must practice two effective methods of birth control (condom with spermicide or abstinence) and must use such precautions from Screening until the end of the study 3. Ability and willingness to give written informed consent; 4. No clinically significant abnormal findings on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory profiles of both blood and urine

1. Pazienti con Iperlipidemia di tipo II aventi i seguenti valori di lipidi: - C-HDL: maschi ≤44 mg/dL (≤1,13 mmol/L), femmine ≤54 mg/dL (≤1,39 mmol/L); - C-LDL: ≥130 mg/dL (≥3,33 mmol/L); 2. Maschio o femmina, da 18 a 70 anni di età, compresi. Le pazienti di sesso femminile devono essere in post-menopausa o chirurgicamente sterili. La post-menopausa è definita come amenorrea per almeno 24 mesi consecutivi e un livello di ormone follicolostimolante (FSH) ≥30 UI/L. I pazienti di sesso maschile, se non chirurgicamente sterile, deve praticare due metodi anticoncezionali efficaci (preservativo con spermicida o astinenza) e deve adottare tali precauzioni dallo Screening fino al termine dello studio. 3. Capacità e volontà di fornire il consenso informato scritto. 4. Nessun reperto anomalo clinicamente significativo all’anamnesi medica, all’esame fisico, nei segni vitali, nell’ECG a 12 derivazioni e nei profili del laboratorio clinico sia sul sangue che sull’urina.

E.4

Principal exclusion criteria

1.Patients with a significant cardiac disease prior to enrollment, such as myocardial infarction, heart failure, coronary or peripheral artery angioplasty, bypass graft surgery, severe or unstable angina pectoris, cardiac arrthymias, hypertension or any other disease which requires treatment; 2.Uncontrolled diabetes (HbA1c >8.0%); 3.History of symptomatic cerebrovascular disease prior to enrollment, such as symptomatic carotid artery disease, cerebrovascular hemorrhage, transient ischemic attack or carotid endarterectomy or any disease which requires treatment; 4.History of clinically significant hematologic, renal, hepatic, neurologic, endocrinal, oncologic, pulmonary, immunologic or psychiatric disorders; 5.Any current or recent (within four weeks of Visit 2 [Start of Placebo run-in period [Day -14]) concomitant therapy (apart from paracetamol and NSAIDS). Patients on previous concomitant treatment may enter the study if the treatment has been discontinued, when appropriate and if ethically justified, at least four weeks prior to Visit 2 (Wash-out period to be performed prior to enter in the Run-in period); 6.Body Mass Index (BMI) > 35 kg/m²; 7.Positive for hepatitis B, C, or HIV and known history or current TB; 8.Positive drug screen result (i.e. cocaine, opiates, amphetamine, cannabis, barbiturates, benzodiazepines, and/or methadone); 9.Pregnant, breast feeding, or women with child-bearing potential; 10.Regular use of non-drug therapies such as garlic supplement and St John’s Wort; 11.Presence or history of alcoholism or drug abuse; 12.Use of more than 21 units of alcohol per week for males or more than 14 units of alcohol per week for females or more than four (men) or three (women) units in any one day (1 alcohol unit is equal to 25 ml of vodka, 85 ml of wine, 284 ml light beer approximately); 13.Smoking (10 or more cigarettes a day) within 3 months prior to screening; 14.Relevant drug hypersensitivity or allergy or any serious adverse reaction to lipid regulating agents; 15.Administration of study drug in an investigational drug study within 90 days prior to enrollment and participation in another drug trial from Screening until Follow-up; 16.Any surgical or medical condition which can make unsuitable the patient to participate in the study in the opinion of the Investigator

1. Pazienti con patologia cardiaca significativa prima dell’arruolamento, come infarto miocardico, angioplastica coronarica o delle arterie periferiche. Intervento di bypass, angina pectoris grave o instabile, aritmie cardiache, ipertensione o qualsiasi altra malattia che richieda trattamento; 2. Diabete non controllato (HbA1c >8,0%); 3. Anamnesi di patologia cerebrovascolare sintomatica prima dell’arruolamento, come patologia sintomatica dell’arteria carotidea, emorragia cerebrovascolare, attacco ischemico transitorio o endarterectomia carotidea o qualsiasi patologia che necessiti di trattamento; 4. Storia di disturbi ematologici, renali, epatici, neurologici, endocrini, oncologici, polmonari, immunologici o psichiatrici clinicamente significativi; 5. Qualsiasi terapia concomitante (a parte paracetamolo e FANS) attuale o recente (entro quattro settimane dalla Visita 2 [inizio del periodo di Run-in con placebo [Giorno -14]). I pazienti in trattamento concomitante precedente possono entrare nello studio se il trattamento è stato interrotto, se eticamente appropriato e giustificato, almeno quattro settimane prima della Visita 2 (periodo di wash-out da effettuare prima di entrare nel periodo di Run-in); 6. Indice di massa corporea (BMI) > 35 kg/m²; 7. Positivi per epatite B, C o HIV e anamnesi nota o attuale di tubercolosi; 8. Risultato positivo allo Screening di sostanze stupefacenti (ovvero, cocaina, oppiacei, anfetamina, cannabis, barbiturati, benzodiazepine e/o metadone); 9. Donna in gravidanza, allattamento o potenzialmente fertile; 10. Uso regolare di terapie non farmacologiche come integratori con aglio o erba di San Giovanni; 11. Presenza o anamnesi di alcolismo o abuso di sostanze stupefacenti; 12. Uso di più di 21 unità di alcol per settimana per gli uomini o più di 14 unità di alcol per settimana per le donne o più di quattro (uomini) o tre (donne) unità in qualsiasi singolo giorno (1 unità di alcol è pari a circa 25 ml di vodka, 85 ml di vino, 284 di birra leggera); 13. Fumo (10 o più sigarette al giorno) nei 3 mesi precedenti lo Screening; 14. Rilevante ipersensibilità o allergia a farmaci o qualsiasi grave reazione avversa agli agenti di regolazione dei lipidi; 15. Somministrazione del farmaco in esame in uno studio con farmaco sperimentale nei 90 giorni prima dell’arruolamento e partecipazione ad un’altra sperimentazione su farmaci dallo Screening fino al Follow-Up; 16. Qualsiasi condizione medica o chirurgica che può rendere il paziente inadatto a partecipare allo studio, secondo il parere dello sperimentatore.

E.5 End points

E.5.1

Primary end point(s)

Percentage change in HDL-C from baseline (Visit 3) to end of double-blind treatment (Visit 6)

Differenza percentuale in HDL-C tra Baseline (Visita 3) e fine trattamento in doppio cieco (Visita 6)

E.5.1.1

Timepoint(s) of evaluation of this end point

From Visit 3 to the end of double-blind treatment (Visit 6)

Dalla Visita 3 al termine del trattamento in doppio cieco (Visit 6)

E.5.2

Secondary end point(s)

•Percent change from baseline in TC, LDL-C, HDL C/LDL-C ratio, triglycerides and apolipoproteins (Apo A-I, Apo-B, Apo-E and Lp(a)). •Percentage of inhibition of CETP

•Differenza percentuale tra i valori di baseline in TC, LDL-C, rapporto HDL C/LDL-C, trigliceridi e apolipoproteine (Apo A-I, Apo-B, Apo-E and Lp(a)). •Percentuale di inibizione di CETP

E.5.2.1

Timepoint(s) of evaluation of this end point

Visit 6

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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)

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

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

Ukraine

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

LVLS

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

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

225

F.4.2.2

In the whole clinical trial

365

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

No treatment or care which is different form the expected normal treatment

Nessun trattamento o cura diversa dal trattamento standard atteso

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

2011-06-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-04-10

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