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    Summary
    EudraCT Number:2005-002851-41
    Sponsor's Protocol Code Number:1228.1
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-27
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2005-002851-41
    A.3Full title of the trial
    Reduced factorial design, randomized, double blind trial comparing combinations of telmisartan 20 or 80 mg and simvastatin 20 or 40 mg with single component therapies in the treatment of hypertension and dyslipidemia.
    A.4.1Sponsor's protocol code number1228.1
    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 SponsorBoehringer Ingelheim Pharma Ges mbH
    B.1.3.4CountryAustria
    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 Information not present in EudraCT
    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 nameMicardis 80 mg
    D.3.4Pharmaceutical form 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 INNtelmisartan
    D.3.9.1CAS number 144701-48-4
    D.3.9.2Current sponsor codeBIBR 277
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameMicardis 20 mg
    D.3.4Pharmaceutical form 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 INNtelmisartan
    D.3.9.1CAS number 144701-48-4
    D.3.9.2Current sponsor codeBIBR 277
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 nameZocor
    D.3.4Pharmaceutical form Capsule, hard
    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 INNsimvastatin
    D.3.9.1CAS number 79902-63-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    hypertension and dyslipidaemia

    ICD classification codes:
    I10 Essential (primary) hypertension
    E78.2 Mixed hyperlipidaemia
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The first primary objective of this trial is to demonstrate that combinations of telmisartan (T20 mg and T80 mg) and simvastatin (S20 mg and S40 mg) have similar efficacy in reducing 24 hour mean DBP compared to the respective telmisartan monotherapy, and have similar efficacy in reducing LDL cholesterol compared to the respective simvastatin monotherapy. This will be shown by confirming that the combinations are non inferior in the reduction of mean DBP compared to telmisartan alone, and in the reduction of LDL cholesterol compared to simvastatin alone, in patients with hypertension and hypercholesterolemia.
    E.2.2Secondary objectives of the trial
    The secondary aim of this trial is to demonstrate that combinations of telmisartan (T20 mg and T80 mg) with simvastatin (S20 mg and S40 mg) are superior in the reduction of mean DBP compared to simvastatin alone, and in the reduction of LDL cholesterol compared to telmisartan alone, in patients with hypertension and hypercholesterolemia.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Male or female patients with all of the following inclusion criteria will be considered for randomization:
    1.) Willing and able to provide written informed consent
    2.) Age 18 years or older
    3.) Hypertension as defined by a mean seated cuff DBP of ≥ 95 – 109 mmHg at visit 3.1
    4.) Hypercholesterolemia as defined by a fasting LDL-C level at visit 2 according to CV risk shown in table in Protocol, page 29
    E.4Principal exclusion criteria
    1.) pre-menopausal women (last menstruation ≤ 1 year prior to informed consent) who are not surgically sterile; or are nursing or pregnant; or are of child-bearing potential and are not practicing acceptable means of birth control, do not plan to continue using this method throughout the trial and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable means of birth control include the transdermal patch, oral, implantable or injectable contraceptives, Intra Uterine Devices (IUDs), sexual abstinence and vasectomised partner. No exceptions will be made.

    2.) inability to stop current antihypertensive and/or cholesterol-lowering therapies for reason of unacceptable risk to the patient (Investigator’s discretion)

    3.) contra-indication to a washout/placebo treatment (e.g. stroke or transient ischemic attacks within the past six months, myocardial infarction, cardiac surgery, percutaneous transluminal coronary angioplasty, unstable angina or coronary artery bypass graft within the past three months of signing the informed consent form)

    4.) clinically relevant cardiac arrhytmias (e.g. ventricular tachycardia, atrial fibrillation, atrial flutter) as determined by the investigator

    5.) hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve

    6.) mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥ 110 mmHg during washout and run-in at two consecutive visits (up to and including visit 3.2)

    7.) known or suspected secondary hypertension (e.g., primary aldosteronism)

    8.) known or suspected secondary hyperlipidemia of any etiology, such as nephrotic syndrome, hypothyroidism, dysproteinemia, obstructive liver disease, or Cushing’s syndrome

    9.) diabetes that has not been stable and controlled (HbA1C ≥ 10%) for the previous three months

    10.) severe renal dysfunction as defined by serum creatinine > 3.0 mg/dL (>265 µmol/L) or creatinine clearance < 0.6 ml/sec

    11.) bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant or with only one kidney

    12.) biliary obstructive disorders, hepatic insufficiency, including past or current liver disease or unexplained elevations (>2 times upper limit of normal range) of SGOT (AST) or SGPT (ALT)

    13.) clinically relevant hypokalaemia or hyperkalaemia

    14.) uncorrected volume depletion

    15.) uncorrected sodium depletion

    16.) any history of myopathy or rhabdomyolysis during the past treatment with HMG Co-A reductase inhibitors

    17.) concurrent use of large quantities of grapefruit juice (> 1L each day) and drugs know to increase simvastatin concentrations and consequently the risk of myopathy / rhabdomyolysis (see drug restriction list)

    18.) known hypersensitivity or intolerance to HMG Co-A reductase inhibitors and/or angiotensin receptor blockers, or to any of the components within the trial medications; patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin-II receptor antagonists

    19.) hereditary fructose intolerance

    20.) planned significant diet and/or lifestyle (including exercise) changes during the treatment phase of the trial

    21.) history of drug or alcohol dependency within six months prior to signing the informed consent or ongoing excessive alcohol consumption (>21 drinks each week)

    22.) any investigational drug therapy within one month of providing informed consent

    23.) any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medications
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline to the end of trial (8 weeks) of 24-hour ABPM measured mean DBP and LDL-cholesterol levels in the combination groups as compared to the single (active) component groups:
    • absolute change from baseline to the end of trial of 24-hour mean DBP for low dose telmisartan combined with high dose simvastatin (T20/S40) as compared to low dose telmisartan (T20)

    • absolute change from baseline to the end of trial of 24-hour mean DBP for high dose telmisartan combined with high dose simvastatin (T80/S40) as compared to high dose telmisartan (T80)

    • percent change from baseline to the end of trial of LDL cholesterol for high dose telmisartan combined with low dose simvastatin (T80/S20) as compared to low dose simvastatin (S20)

    • percent change from baseline to the end of trial of LDL cholesterol for high dose telmisartan combined with high dose simvastatin (T80/S40) as compared to high dose simvastatin (S40)

    The second primary endpoint is the change from baseline to the end of trial (8 weeks) of 24-hour ABPM measured mean DBP and LDL cholesterol levels in the combination groups as compared to the single (suggested non-active) component:
    • absolute change from baseline to the end of trial of 24-hour mean DBP for high dose telmisartan combined with low dose simvastatin (T80/S20) as compared to low dose simvastatin (S20)
    • absolute change from baseline to the end of trial of 24-hour mean DBP for high dose telmisartan combined with high dose simvastatin (T80/S40) as compared to high dose simvastatin (S40)

    • absolute change from baseline to the end of trial of 24-hour mean DBP for low dose telmisartan combined with high dose simvastatin (T20/S40) as compared to high dose simvastatin (S40)

    • percent change from baseline to the end of trial of LDL cholesterol for low dose telmisartan combined with high dose simvastatin (T20/S40) as compared to low dose telmisartan (T20)

    • percent change from baseline to the end of trial of LDL cholesterol for high dose telmisartan with high dose simvastatin (T80/S40) as compared to high dose telmisartan (T80)

    • percent change from baseline to the end of trial of LDL cholesterol for high dose telmisartan combined with low dose simvastatin (T80/S20) as compared to high dose telmisartan (T80)
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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.8.5The trial involves multiple Member States Yes
    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 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
    telephone call one week after last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 Information not present in EudraCT
    F.3.3.1Women 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 2006-02-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 2000
    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 Decision2006-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-10
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