Clinical Trials Register

Summary
EudraCT Number:	2006-005556-32
Sponsor's Protocol Code Number:	olmitiaz-02
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:	2007-09-14
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

2006-005556-32

A.3

Full title of the trial

Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy versus Olmesartan Medoxomil 40 mg Monotherapy in Patients with Essential Hypertension

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

olmitiaz-02

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	MENARINI RICERCHE S.P.A.
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	Information not present in EudraCT
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	Olmesartan Medoxomil/Hydrochlorothiazide
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.3.9.1	CAS number	144689-63-4
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
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	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	PLAUNAC*28CPR RIV 40MG
D.2.1.1.2	Name of the Marketing Authorisation holder	MENARINI INTERNAT. O.L.S.A
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Olmesartan medoxomil
D.3.9.1	CAS number	144689-63-4
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

hypertension

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10015488
E.1.2	Term	Essential hypertension

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 anti-hypertensive effect of Olmesartan Medoxomil/ Hydrochlorothiazide (OM/HCTZ) 40/12.5 mg combination therapy compared to Olmesartan Medoxomil (OM) 40 mg monotherapy in lowering sitting diastolic blood pressure (dBP) in hypertensive patients after 8 weeks of double-blind treatment (from baseline to the end of the first double-blind treatment phase of the study).

E.2.2

Secondary objectives of the trial

1. To assess the anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting systolic blood pressure in hypertensive patients after 8 weeks of double-blind treatment.

2. To evaluate the percentage of responders in each treatment group after the first 8 weeks of treatment and in up-titrated patients after 16 weeks of treatment.

3. To compare the efficacy in lowering sitting dBP and sBP between patients up-titrated from OM/HCTZ 40/12.5 mg to OM/HCTZ 40/25 mg and patients continuing on OM/HCTZ 40/12.5 mg after 16 weeks of treatment compared to week 8.

4.To compare the efficacy in lowering sitting dBP and sBP between patients up-titrated from OM 40 mg monotherapy to OM/HCTZ 40/12.5 mg and patients continuing on OM 40 mg after 16 weeks of treatment compared to week 8.

5. 5. To evaluate the safety and tolerability of the combinations OM/HCTZ 40/12.5 mg and OM/HCTZ 40/25 mg versus OM 40 mg monotherapy.

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

1. Male or female Caucasian patients ≥ 18 years of age. A female of childbearing potential may be enrolled providing she:

- has a negative pregnancy test at screening/enrolment and randomisation, and

- is routinely using a highly effective method of birth control resulting in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, e.g. implants, injectables, combined oral contraceptives, hormone containing intra uterine devices (IUDs).

2. Patients with a diagnosis of essential hypertension, either treatment-naive or currently on anti-hypertensive medication in whom it is medically justifiable to withdraw treatment, and who are likely to meet the required BP inclusion criteria at randomisation (see inclusion criteria No. 3 below).

3. BP criteria at randomisation:

a) Mean sitting dBP ≥ 100 mmHg and ≤ 120 mmHg.

b) Mean sitting sBP ≥ 160 mmHg and ≤ 200 mmHg.

4. Patients who have freely given written informed consent.

E.4

Principal exclusion criteria

1. Patients with mean sitting sBP values > 200 mmHg and/or dBP > 120 mmHg.

2. Pregnant or nursing women.

3. Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the tested medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological, oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients.

4. Patients having a history of the following within the last six months: Myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischaemic attack.

5. Patients with clinically relevant significant abnormal laboratory values at screening/enrolment, including patients with:

aspartate aminotransferase/serum glutamic-oxaloacetic-transaminase (ASAT/SGOT) and alanine aminotransferase/serum glutamic – pyruvate - transaminase (ALAT/SGPT) greater than twice the upper limit and/or gamma-glutamyltransferase (γ-GT) greater than three times the upper limit of laboratory reference range

and/or

potassium above the upper limit of laboratory reference range (unless high value is due to haemolytic blood sample).

6. Patients with secondary hypertension of any aetiology such as renal disease, pheochromocytoma, or Cushing’s syndrome.

7. Patients with contraindication to Hydrochlorothiazide (HCTZ) and/or OM.

8. Patients with electrocardiographic evidence of 2nd or 3rd degree atrioventricular (AV)-block, atrial fibrillation or other cardiac arrhythmia (requiring treatment), or bradycardia (< 50 beats/min as measured by mean radial heart rate).

9. Patients with severe heart failure (New York Heart Association stage III-IV), a narrowing of the aortic or bicuspid valve, an obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease.

10. Patients with clinical evidence of a renal disease (including renovascular occlusive disease, nephrectomy and/or renal transplant, bilateral renal artery stenosis or unilateral renal artery stenosis in a solitary kidney, or severe renal impairment as evidenced by creatinine clearance (CLCR) < 30 mL/min).

11. Patients with uncorrected coarctation of aorta and higher grades of acquired aortic stenosis.

12. Patients with clinically relevant hepatic impairment.

13. Patients with biliary obstruction.

14. Poorly controlled diabetic patients, defined as Type 1 or Type 2 patients with a fasting glucose >12.21 mmol/L [>220 mg/dL].

15. Patients with a history of a wasting disease (e.g. cancer), autoimmune diseases, connective tissue diseases, major allergies, or angioneurotic oedema.

E.5 End points

E.5.1

Primary end point(s)

Change in mean trough sitting dBP between baseline and week 8 or last observation carried forward (LOCF).

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

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 2007-09-14.	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	72
F.4.2	For a multinational trial
F.4.2.1	In the EEA	1196
F.4.2.2	In the whole clinical trial	1400

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

2007-08-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-05-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2008-08-27

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