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    Summary
    EudraCT Number:2015-001890-42
    Sponsor's Protocol Code Number:CLHW090X2202
    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:2015-10-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-001890-42
    A.3Full title of the trial
    A randomized, sponsor open, site and subject double-blind, parallel group, placebo-controlled study to evaluate the safety and efficacy of LHW090 after 4 weeks treatment in patients with resistant hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the safety and efficacy of LHW090 in patients with resistant hypertension
    A.4.1Sponsor's protocol code numberCLHW090X2202
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41613241111
    B.5.5Fax number41613248001
    B.5.6E-mailclinicaltrialenquiries@novartis.com
    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 No
    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 nameLHW090
    D.3.2Product code LHW090
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNnot established
    D.3.9.2Current sponsor codeLHW090
    D.3.9.3Other descriptive nameLHW090-NXA and NVP-LHW090
    D.3.9.4EV Substance CodeSUB176354
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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, 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
    Resistant hypertension
    E.1.1.1Medical condition in easily understood language
    High blood pressure not controlled
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10015491
    E.1.2Term Essential hypertension, unspecified
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether LHW090 displays the clinical safety and efficacy profile to support further development in patients with resistant hypertension: i.e
    - To assess the safety and tolerability of LHW090 for 4 weeks on a background of conventional anti-hypertensive medications in patients with resistant hypertension.
    - To evaluate the effect of LHW090 on placebo-adjusted mean daytime systolic blood pressure (SBP) after 4 weeks in patients with resistant hypertension.

    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetics (PK) of LHW090 and its active metabolite LHV527 in patients with resistant hypertension.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any assessment is performed.
    2. Male and female patients, age 40 to 85 years inclusive.
    3. Demonstrating a ≥ 80% medication compliance rate during the single-blind run-in period.
    4. Patients with uncontrolled hypertension (here defined as having a daytime systolic BP ≥ 135 mmHg by ABPM at screening) despite
    treatment with a stable (at least 1 month) regimen that includes an optimal doses of an ARB plus a diuretic (thiazide or loop) plus at least one class of anti-hypertensive medication
    For the purposes of this trial, optimal doses of anti-hypertensive medications are defined as:
     a) the highest dose listed in the clinical practice guideline from the American Society for Hypertension and the International Society for Hypertension [Weber, et al. 2014] or
     b) the highest allowable prescribed dose per the manufacturer's label or
     c) the highest dose tolerated by an individual patient or
     d) the highest dose appropriate for an individual patient in the judgment of the Investigator
    5. Subjects must weigh at least 45 kg to participate in the study and must have a body mass index (BMI) within the range of 18-40kg/m2.
    6. Able to communicate well with the investigator, to understand and comply with the requirements of
    the study.

    Other protocol defined inclusion criteria may apply
    E.4Principal exclusion criteria
    Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives of enrollment, whichever is longer; or longer if
    required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
    2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
    3. Patients with an estimated GFR <60 ml/min/1.73m2 at screening using the MDRD equation.
    4. Use of angiotensin converting enzyme inhibitors (ACE-inhibitors).
    Note: Patients who discontinue their ACE-inhibitor and substitute with an angiotensin receptor blocker may be eligible to be re-screened
    provided their anti-hypertensive regimen has been stable for at least 1 month. Any substitutions or changes to a patient's anti-hypertensive
    regimen should be done under the guidance of the patient's treating physician.
    5. History of angioedema, drug related or otherwise, as reported by the patient.
    6. Clinically significant ECG abnormalities at screening as determined by the Investigator.
    7. Severe hypertension as defined by an office systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥110 mmHg at screening or baseline.
    8. A history of secondary hypertension of any etiology including but not limited to unilateral or bilateral renal artery stenosis, polycystic kidney
    disease, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, and drug-induced hypertension. If the
    patient has not been evaluated for secondary hypertension, investigators are responsible to evaluate all potential secondary causes of
    hypertension considering clinical history, physical examination, laboratory investigations or other relevant diagnostic measures in
    accordance with current practices and clinical guidelines before entering the patient into the study.
    9. Known current significant left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or significant severe valvular disease on prior or current echocardiogram).
    10. A history of known moderate or malignant hypertensive retinopathy defined as moderate (retinal signs of hemorrhage), microaneurysms,
    cotton-wool spots, hard exudates, or a combination thereof) or malignant (signs of moderate retinopathy plus swelling of the optic
    disk). Patients with a stable ophthalmologic history in the past 6 months are eligible. Any new or progressive retinal changes, acute glaucoma or
    other ophthalmologic conditions within the past 6 months should be evaluated by the treating ophthalmologist during screening.
    11. To facilitate ABPM assessment of daytime readings, an upper arm circumference greater than 42 cm or third shift or overnight workers.
    12. History within the previous 6 months of myocardial infarction, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), hypertensive encephalopathy, stroke, or transient ischemic attack (TIA).
    13. Hemoglobin levels below 9.0 g/dL at screening.
    14. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or
    untreated, within the past 1 year, regardless of whether there is evidence of local recurrence or metastases.
    15. Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation.
    16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
    17. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
    18. Sexually active males must use a condom during intercourse while taking drug and for 1 week after stopping study medication and should
    not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal
    fluid.
    19. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her
    participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
    20. On the Columbia-Suicide Severity Rating Scale score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation
    occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self Injurious Behavior"if this behavior occured in the past 2 years. Any patient meeting this exclusion criterion should be referred to a mental health care professional.
    21. Vulnerable subjects, e.g. subjects kept in detention, soldiers and employees of the sponsor or a clinical research organization, involved in
    this study.
    Other protocol defined exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    Safety endpoints (adverse events, serious adverse events) will be measured up to and including end of study assessments

    The primary efficacy variable will be the change in the 12 hour average of systolic blood pressure
    measured by ambulatory blood pressure monitoring (ABPM) 28 days following the start of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Efficacy and Safety parameters will be routinely evaluated over the 4 weeks of treatment as defined in the protocol
    -ABPM measured at baseline and at the end of the treatment at day 28
    E.5.2Secondary end point(s)
    Pharmacokinetics (PK) parameters of LHW090 and its active metabolite LHV527 in patients with resistant hypertension.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As defined in the protocol : PK parameters will be measured on Day 28 (Cmax, Tmax, AUClast, AUC0-t)
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    sponsor open study
    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.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Switzerland
    United States
    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
    LVLS
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days19
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 80
    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)
    If the study completes positively, further development will be considered in resistant hypertension.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-08-17
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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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