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    Summary
    EudraCT Number:2006-005556-32
    Sponsor's Protocol Code Number:CS866CM-B-E303
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-23
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2006-005556-32
    A.3Full 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.4.1Sponsor's protocol code numberCS866CM-B-E303
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMenarini Ricerche S.p.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Benicar HCT®
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCombination of Olmesartan Medoxomil and Hydrochlorothiazide
    D.3.2Product code OM/HCTZ
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOLMESARTAN MEDOXOMIL
    D.3.9.1CAS number 144689-6-34
    D.3.9.2Current sponsor codeOM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHYDROCHLOROTHIAZIDE
    D.3.9.1CAS number 58-93-5
    D.3.9.2Current sponsor codeHCTZ
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Benicar HCT®
    D.2.1.1.2Name of the Marketing Authorisation holderDaiichi Sankyo Pharma
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCombination of Olmesartan Medoxomil and Hydrochlorothiazide
    D.3.2Product code OM/HCTZ
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOLMESARTAN MEDOXOMIL
    D.3.9.1CAS number 144689-6-34
    D.3.9.2Current sponsor codeOM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHYDROCHLOROTHIAZIDE
    D.3.9.1CAS number 58-93-5
    D.3.9.2Current sponsor codeHCTZ
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Olmetec®
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini Int'l Operations Luxembourg S.A.
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOlmesartan Medoxomil
    D.3.2Product code OM
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOLMESARTAN MEDOXOMIL
    D.3.9.1CAS number 144689-6-34
    D.3.9.2Current sponsor codeOM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Essential hypertension
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10015488
    E.1.2Term Essential hypertension
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.2.2Secondary objectives of the trial
    1. Assess 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. Evaluate 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. 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. 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. 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.2.3Trial contains a sub-study No
    E.3Principal 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.4Principal 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 IIIIV),
    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.
    16. Patients being treated for other diseases with drugs or medication which
    may influence BP or interfere with the objectives of the study and which
    cannot be withdrawn during the period of the study (e.g. alpha-blockers
    for the treatment of benign prostatic hypertrophy or intra-ocular betablockers
    for the treatment of glaucoma).
    17. Patients being treated at randomisation with any antihypertensive
    medication (e.g. calcium channel-blockers, angiotensin II receptor
    blocker, diuretics, α- and β-blocking agents, angiotensin converting
    enzyme [ACE] inhibitors, reserpine).
    18. Patients with known malabsorption syndromes.
    19. Patients who have shown non-compliance with medication and study
    procedures during the single-blind placebo run-in phase.
    20. Patients with psychiatric or emotional problems, which would invalidate
    the giving of informed consent or limit the ability of the patient to comply
    with study requirements.
    21. Patients with a history of alcohol and/or drug abuse.
    22. Patients unwilling or unable to tolerate discontinuation of their previous
    medication.
    23. Patients who have donated 450 ml or more blood during the last three
    months before screening/enrolment.
    24. Patients who have received an investigational drug within 30 days prior
    to screening/enrolment.
    25. Patients who are unwilling or unable to provide informed consent or to
    participate satisfactorily for the entire study period.
    E.5 End points
    E.5.1Primary 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.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    2 week single-blind placebo run-in phase prior to randomisation
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    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.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state232
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1196
    F.4.2.2In the whole clinical trial 1400
    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)
    Please refer to protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-05-28
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