Clinical Trials Register

Summary
EudraCT Number:	2010-019155-22
Sponsor's Protocol Code Number:	M13-385
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-06-11
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

Germany - BfArM

A.2

EudraCT number

2010-019155-22

A.3

Full title of the trial

A Prospective, Randomized, Double-Blind, Parallel-Group Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects with Essential Hypertension

A.3.1

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

A Study to Compare the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Subjects with High Blood Presure

A.4.1

Sponsor's protocol code number

M13-385

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	Abbott Healthcare Products B.V.
B.1.3.4	Country	Netherlands
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	Abbott Healthcare Products B.V.
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Abbott Healthcare Products B.V.
B.5.2	Functional name of contact point	Dmitri Kazei
B.5.3	Address:
B.5.3.1	Street Address	C.J. van Houtenlaan 36
B.5.3.2	Town/ city	Weesp
B.5.3.3	Post code	1381CP
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	003129447 7008
B.5.5	Fax number	---
B.5.6	E-mail	dmitri.kazei@abbott.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	Eprosartan
D.3.4	Pharmaceutical form	Tablet
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.3.8	INN - Proposed INN	EPROSARTAN
D.3.9.1	CAS number	133040-01-4
D.3.9.4	EV Substance Code	SUB06586MIG
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	450
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	TEVETEN® Mono 600 mg,
D.2.1.1.2	Name of the Marketing Authorisation holder	Abbott Arzneimittel GmbH,
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	TEVETEN® Mono 600 mg
D.3.4	Pharmaceutical form	Tablet
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.3.8	INN - Proposed INN	EPROSARTAN MESILATE
D.3.9.1	CAS number	144143-96-4
D.3.9.3	Other descriptive name	EPROSARTAN MESYLATE
D.3.9.4	EV Substance Code	SUB01920MIG
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	600
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Essential Hypertension

E.1.1.1

Medical condition in easily understood language

High blood pressure where the cause of the high blood pressure is unknown.

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	10015488
E.1.2	Term	Essential hypertension
E.1.2	System Organ Class	10047065 - Vascular 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 therapeutic equivalence of eprosartan (a new formulation containing only the active moiety eprosartan) with eprosartan mesylate (currently marketed formulation) on sitting diastolic blood pressure (DBP) in ambulatory subjects with mild to moderate essential hypertension after 8 weeks of treatment (monotherapy).

E.2.2

Secondary objectives of the trial

To compare the effect of eprosartan with eprosartan mesylate on sitting systolic blood pressure (SBP), responder rate, and normalization rate after 8 weeks (monotherapy) and 12 weeks (add-on therapy) of treatment, and on sitting trough blood pressure at 12 weeks.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female aged ≥ 18 years

2. Subjects with history of mild to moderate essential hypertension for at least 2 months and with mean sitting SBP ≥ 140 mmHg and ≤ 179 mmHg; and mean sitting DBP ≥ 90 mmHg and ≤ 109 mmHg at screening (V1) and at baseline (V2)

3. Written informed consent to participate in the study before starting any study-specific procedures at V1 (screening)

4. Compliance with the study medication > 80% and < 120% during the 3-week placebo washout period.

E.4

Principal exclusion criteria

1. Women of childbearing potential without hormonal, barrier or intrauterine contraception methods

2. Inability to discontinue all prior antihypertensive medications safely for the duration of the washout period, subjects on triple combination of antihypertensive drugs at V1 or subjects on dual combination with moderate hypertension (SBP≥160-179 mmHg and/or DBP ≥100-109 mmHg) at V1

3. Pregnant or breast-feeding female subject

4. Any secondary form of hypertension

5. Severe (Grade 3) hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg)

6. Presence of the differences greater than 20mmHg for SBP and 10mmHg for DPB on 3 consecutive readings at V1 or V2

7. Angina pectoris that is currently being treated with long acting nitrates, beta-blockers, or calcium channel blockers unless kept on stable doses for the duration of the study

8. Severe diabetes mellitus (HbA1c greater 8.5%) with metabolic complications (diabetic ketoacidosis, hyperosmolar hyperglycemia associated with dehydration)

9. Nonresponders to ACE inhibitors or angiotensin receptor blockers (ARBs), however, subjects known to be intolerant to ACE inhibitors are allowed

10. Concomitant administration of lithium and NSAIDs except for a low-dose aspirin (75-325mg per day)

11. New York Heart Association (NYHA) Class IV congestive heart failure

12. Myocardial infarction or unstable angina within the preceding 90 days

13. Aortic and mitral valve stenosis, hypertrophic cardiomyopathy

14. Known or suspected hemo-dynamically significant bilateral renal artery stenosis or severe stenosis of a solitary functioning kidney

15. Severe renal impairment (creatinine clearance < 30 mL/min)

16. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 times the upper limit of normal and/or total bilirubin > 3 mg/dL

17. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

18. Active alcohol or drug abuse

19. Known hypersensitivity to the active substances of eprosartan or to any of its excipients, or to sulfonamide derived substances (such as HCTZ)

20. Administration of an investigational drug or device, or participation in an investigational trial within 30 days

21. Clinically significant laboratory abnormalities or medical conditions which, in the opinion of the Investigator, make them unsuitable for evaluation

22. Subjects withdrawn from the study cannot re-enter this trial

E.5 End points

E.5.1

Primary end point(s)

Change in trough sitting DBP from baseline to end of Week 8.

E.5.1.1

Timepoint(s) of evaluation of this end point

8 weeks

E.5.2

Secondary end point(s)

1. Change in trough sitting SBP from baseline (V2) to end of Week 8 (V4).
2. Change in trough sitting DBP and trough sitting SBP from baseline (V2) to end of Week 12 (V5).
3. Responder rate at Week 8 (V4) and at Week 12 (V5) on monotherapy.
4. Normalization rate at Week 8 (V4) and Week 12 (V5) on monotherapy.
5. Responder rate at Week 12 (V5) in subjects with add-on HCTZ.
6. Normalization rate at Week 12 (V5) in subjects with add-on HCTZ.

E.5.2.1

Timepoint(s) of evaluation of this end point

8 and/or 12 Weeks

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

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)

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.8.2.4

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

Germany

Russian Federation

United Kingdom

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

Last visit of the last subject

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.1.1.1

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:

425

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

240

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

345

F.4.2

For a multinational trial

F.4.2.1

In the EEA

565

F.4.2.2

In the whole clinical trial

665

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

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

2012-06-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-04-30

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