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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-004966-17
    Sponsor's Protocol Code Number:H8D-MC-EMBH
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-06-01
    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 ConcernedSweden - MPA
    A.2EudraCT number2005-004966-17
    A.3Full title of the trial
    PPAR Alpha (LY518674): a Phase 2 Dose-Response Study to Evaluate the Blood Pressure-Lowering Effect in Essential Hypertension
    A.3.2Name or abbreviated title of the trial where available
    EMBH
    A.4.1Sponsor's protocol code numberH8D-MC-EMBH
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 nameLY518674
    D.3.4Pharmaceutical form Capsule*
    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.3.9.2Current sponsor codeLY518674
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLY518674
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 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 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 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 nameHCT 12,5 - 1A Pharma
    D.3.2Product code HCTZ
    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 INNhydrochlorothiazide
    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 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 placeboCapsule*
    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
    mild essential hypertension
    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
    to test the hypothesis that LY518674, administered for 6 weeks to patients with mild essential hypertension, reduces 24-hour mean ambulatory SBP, compared with placebo.
    E.2.2Secondary objectives of the trial
    •Determine the duration and consistency of the reduction in BP over the course of a day, relative to placebo, after 6 weeks of treatment with LY518674 when taken once daily
    •Evaluate the population dose- and exposure-response relationships of LY518674 for lowering the mean SBP and DBP during the 24 -hour and 8-hour awake period
    •Compare the effect of LY518674 on CBPM SBP and DBP with that of placebo.
    •Determine the percentage of responders to LY518674
    •Evaluate the effects of LY518674, relative to placebo, on plasma levels of total TC, LDL-C, HDL-C, TG and hsCRP
    •Evaluate the safety and tolerability effects of LY518674
    ---Additional Objective
    • Blood pressure and safety evaluations associated with the primary and secondary objectives
    ---Specific to Sample Banking
    -associating naturally occurring differences in the serum or plasma or DNA with risk for diseases
    -identifying genetic or protein biomarkers related to the therapeutic response to LY518674 or other compounds
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    [1] Are men and women ≥18 and ≤70 years of age.
    [2] Have given signed informed consent to participate in this study.
    [3] Are diagnosed with mild essential hypertension at screening (currently untreated or treated with monotherapy)
    • CBPM range for untreated patients is SBP 140 to 159 mm Hg and/or DBP 90 to 99 mm Hg.
    • CBPM range for patients on antihypertensive monotherapy is SBP 130 to 150 mm Hg and/or DBP 85 to 95 mm Hg.
    [4] Have two mean CBPM (calculated using the last two of three readings) (SBP 140 to 159 mm Hg and/or DBP 90 to 99 mm Hg) during Study Period 2 (use mean CBPM readings from either of the following: Visit 2 and Visit 4 OR Visit 3 and Visit 4).
    E.4Principal exclusion criteria
    [5] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    [6] Are Lilly employees.
    [7] Have planned or are likely to require major surgery during the course of the study.
    [8] Have any other medical condition, laboratory abnormality, or circumstance prior to randomization, which, in the opinion of the investigator, could affect patient safety, preclude evaluation of response on similar activity days throughout the trial, prohibit the ability to comply with study procedures and restrictions, or completion of the study (for example, swing-shift working conditions).
    [9] Women of child-bearing potential who do not agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of study drug.
    [10] Pregnant or nursing women. Women not surgically sterilized and between menarche and 1 year post menopause must test negative for pregnancy at the time of enrollment based on a serum pregnancy test.
    [11] Are unable, unreliable, and/or unwilling to provide informed consent, make themselves available for the duration of the study, or will not abide by the procedures and study restrictions.
    [12] Have any other condition, which in the opinion of the investigator, precludes the patient from providing informed consent, following the protocol procedures and restrictions, or completing the protocol.
    [13] Have secondary or malignant hypertension.
    [14] Have or have had a history of hyperlipidemia within 3 months of screening requiring treatment according to ESH/ESC guidelines (ESH-ESC 2003).
    [15] Have any previous CV disease other than hypertension.
    [16] Have type 1 or 2 diabetes mellitus.
    [17] Have a body mass index (BMI) >35 kg/m2.
    [18] Have a history of symptomatic postural hypotension or postural dizziness.
    [19] Patient-reported history of human immunodeficiency virus (HIV) infection.
    [20] Have or have had a history of a chronic muscular or neuromuscular disease, including a history of prior rhabdomyolysis, drug-induced myopathy (for example, statin or fibric acid), or an unexplained elevation in CK ≥ 3 x ULN.
    [21] Are currently under suspicion of having cancer or have had a history of cancer in the past 2 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
    [22] Have chronic alcohol or drug abuse or dependency.
    [23] Currently adhering to, have used within 2 months prior to screening, or have plans to adopt diets with aggressive carbohydrate restrictions for weight loss, such as, but not limited to, Atkins or South Beach diets.
    [24] Currently use, have used within 2 months prior to screening, or plan to use during the trial period dietary supplements or over the counter formulations intended for weight loss.
    [25] Have active hepatobiliary disease, serologic evidence of past or active hepatitis B or C, or active gallbladder disease.
    [26] Liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], or total bilirubin >1.5x the upper limit of normal [ULN]).
    [27] Have hemoglobin <105 g/L (10.5 g/dL) in women and <115 g/L (11.5 g/dL) in men.
    [28] Have a serum creatinine >124 μmol/L (1.4 mg/dL) in women, >133 μmol/L (1.5 mg/dL) in men, or nephrotic syndrome, end-stage renal disease and use renal replacement therapy such as hemodialysis or peritoneal dialysis.
    [29] Cardiac troponin I (cTnI) level at or above the lower limit of detection at entry, with the lower limit of detection being defined by the performing reference laboratory.
    [30] Have a history of hypersensitivity or intolerance to drug preparations containing PPAR alpha agonists such as clofibrate, fenofibrate, bezafibrate , or gemfibrozil.
    [31] Patients requiring antihypertensive combination therapy.
    [32] Have received more than one drug that affects blood pressure (examples: chronic steroids or NSAIDs), even if prescribed for another indication, within 2 months prior to the screening visit.
    [33] Drugs whose concomitant use with HCTZ may lead to adverse reactions.
    [34] Have participated within 2 months prior to screening visit in any clinical trials of PPARs consisting of gamma, alpha, delta agonists or gamma, alpha, delta antagonists or partial agonists alone and in any combination.
    E.5 End points
    E.5.1Primary end point(s)
    Change (mm Hg) in mean 24-hour ambulatory SBP from baseline to study end.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state153
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 153
    F.4.2.2In the whole clinical trial 153
    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)
    Not different from expected normal treatment.
    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 Decision2006-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2006-09-29
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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