Clinical Trials Register

Summary
EudraCT Number:	2011-000833-35
Sponsor's Protocol Code Number:	CRLX030A2201
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:	2012-02-27
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

2011-000833-35

A.3

Full title of the trial

A multicenter, phase II, double blind, randomized, parallel group, placebo-controlled study to evaluate the hemodynamic responses to intravenous RLX030 infusion in subjects with acute heart failure.

Uno studio multicentrico, in doppio cieco, randomizzato, per gruppi paralleli, controllato con placebo per valutare le risposte emodinamiche all infusione per via endovenosa di RLX030 in soggetti con insufficienza cardiaca acuta

A.3.1

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

Hemodynamic responses to intravenous RLX030 infusion in patients with acute heart failure

Risposte emodinamiche all’infusione per via endovenosa di RLX030 in soggetti con insufficienza cardiaca acuta

A.4.1

Sponsor's protocol code number

CRLX030A2201

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	NOVARTIS PHARMA AG
B.1.3.4	Country	Switzerland
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	Novartis Pharma Services AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Pharma Arneimittel GmbH
B.5.2	Functional name of contact point	Medizinischer Service
B.5.3	Address:
B.5.3.1	Street Address	Roonstrasse 25
B.5.3.2	Town/ city	Nürnberg
B.5.3.3	Post code	90429
B.5.3.4	Country	Germany
B.5.4	Telephone number	+49 1802232300
B.5.5	Fax number	+49 91127312160
B.5.6	E-mail	infoservice.novartis@novartis.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	RLX030
D.3.2	Product code	RLX030
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.1	CAS number	NA
D.3.9.2	Current sponsor code	RLX030
D.3.9.3	Other descriptive name	RLX030
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Yes
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	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute Heart Failure

Insufficienza cardiaca acuta

E.1.1.1

Medical condition in easily understood language

Acute Heart Failure

Insufficienza cardiaca acuta

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	LLT
E.1.2	Classification code	10000803
E.1.2	Term	Acute heart failure
E.1.2	System Organ Class	10007541 - Cardiac 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 effects on hemodynamic variables of RLX030 administered as i.v. infusion in patients with acute heart failure

Valutare gli effetti sulle variabili emodinamici di RLX030 somministrato come infusione e.v nei pazienti con insufficienza cardiaca acuta

E.2.2

Secondary objectives of the trial

- To assess the on-set and off-set effects of RLX030 administered as i.v. infusion in patients with acute heart failure - To assess the effects of RLX030 administered as i.v. infusion on diuresis and creatinine clearance in patients with acute heart failure - To assess the effects of RLX030 administered as i.v. infusion on central aortic systolic pressure and radial arterial pulse waveform in patients with acute heart failure - To assess the pharmacokinetics of RLX030 administered as i.v. infusion in patients with acute heart failure - To assess the overall safety and tolerability of RLX030 administered as i.v. infusion in patients with acute heart failure

Valutare l`insorgenza e la cessazione di RLX030 somministrato come infusione e.v nei pazienti con insufficienza cardiaca acuta Valutare gli effetti di RLX030 somministrato come infusione e.v sulla diuresi e sulla clearance in pazienti con insufficienza cardiaca acuta Valutare gli effetti di RLX030 somministrato come infusione e.v della pressione sistolica aortica centrale e sulla forma d`€™onda dell`€™arteria radiale nei pazienti con insufficienza cardiaca acuta Valutare la farmacocinetica di RLX030 somministrato come infusione e.v nei pazienti con insufficienza cardiaca acuta Valutare la sicurezza generale e la tollerabilita' di RLX030 somministrato come infusione e.v nei pazienti con insufficienza cardiaca acuta

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients admitted to hospital or who require admission to hospital for management of acute heart failure with shortness of breath at rest or minimal exertion - stabilized within 2 days after admission - normal or elevated systolic blood pressure - elevated pulmonary capilary wedge pressure measured by Swan-Ganz catheterization

Pazienti ricoverati in ospedale o che richiedono ricovero ospedaliero per la gestione dello scompenso cardiaco acuto con dispnea a riposo o con esercizio fisico minimo - stabilizzato entro 2 giorni dopo il ricovero - normale o elevata pressione sistolica - elevata pressione polmonare misurata da Swan-Ganz cateterismo

E.4

Principal exclusion criteria

- severe renal impairment - significant liver impairment - significant lung impairment - significant heart valve dysfunction or arrythmias - myocardial infarction or acute coronary syndrome within th elast 45 days

Insufficienza renale grave insufficienza epatica significativa Insufficienza polmonare significativa Significativa disfunzione delle valvole cardiache o aritmie Infarto miocardico o sindrome coronarica acuta entro gli ultimi 45 giorni

E.5 End points

E.5.1

Primary end point(s)

- Pulmonary capillary wedge pressure (PCWP), - Right atrial pressure (RAP), - Systolic and diastolic pulmonary artery pressure (PAP), - Pulmonary oxygen saturation (pO2) and - Cardiac output (CO)

Pressione polmonare capillare (PCWP) Pressione atriale destra (RAP) Pressione arteriosa polmonare sistolica e diastolica (PAP) Saturazione di ossigeno polmonare (pO2) e gittata cardiaca (CO)

E.5.1.1

Timepoint(s) of evaluation of this end point

At baseline, at 30 minutes, and 2, 4, 6, 8, 20, 22, and 24 hours after start of infusion of study drug

Al basale, a 30 minuti, e 2, 4, 6, 8, 20, 22, e 24 ore dopo l'inizio di infusione del farmaco in studio

E.5.2

Secondary end point(s)

a.Non-invasive measurement of central aortic systolic pressure and radial arterial pulse waveform b.Pharmacokinetics c.Total urine volume d.Safety and tolerability e.Sodium and creatinine excretion

Misurazione della pressione sistolica aortica centrale e e sulla forma d`€™onda dell`€™arteria radiale non invasiva Farmacocinetica Volume totale delle urine Sicurezza e la tollerabilita' Escrezione di sodio e creatinina

E.5.2.1

Timepoint(s) of evaluation of this end point

a. At baseline, at 30 minutes, and 2, 4, 6, 8, 20, 22, and 24 hours after start of infusion of study drug b. At baseline, at 10, 30 minutes, and 2, 8, 20, 22, 24, 27 and 44 hoursand on Day 30 after start of infusion of study drug c.AE/SAE monitoring d. Safety biochemistry and hematology samples taken at baseline and at 8, 20, and 24 hours after start of infusion of study drug and whenever clinically indicated. Blood pressure measured together with central aortic systolic pressure (see. a.) and ECG taken at baseline and at 8, 20, 24, and 44 hours after start of infusion of study

Al basale, a 30 minuti, e 2, 4, 6, 8, 20, 22, e 24 ore dopo l`inizio di infusione del farmaco in studio Al basale, a 10, 30 minuti, e 2, 8, 20, 22, 24, 27 e 44 ore e il giorno 30 dopo l`inizio della infusione del farmaco in studio Monitoraggio degli eventi avversi e degli evanti avversi seri Sicurezza biochimica e campioni ematologici prelevati al basale e 8, 20, e 24 ore dopo l`inizio di infusione del farmaco in studio e quando clinicamente indicato. La pressione sanguigna misurata con la pressione aortica sistolica centrale e un elettrocardiogramma al basale e 8, 20, 24, e 44 ore dopo l`inizio dell`infusione di studio

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

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

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

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

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

Argentina

Russian Federation

E.8.7

Trial has a data monitoring committee

Yes

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

F.4.2.2

In the whole clinical trial

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)

normal treatment of that condition.

normale trattamento per questa condizione clinica

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

2011-09-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-08-02

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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