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    Summary
    EudraCT Number:2005-003606-28
    Sponsor's Protocol Code Number:CVAL489ADE25
    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:2005-11-02
    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 number2005-003606-28
    A.3Full title of the trial
    A 12 week treatment, open-label, multicenter study to investigate the efficacy and safety of valsartan 160-320 mg with regard to effects on lipid subfractions in hypertensive patients with metabolic syndrome
    A.4.1Sponsor's protocol code numberCVAL489ADE25
    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 SponsorNovartis Pharma GmbH
    B.1.3.4CountryGermany
    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 nameDiovan 160 mg
    D.3.2Product code Valsartan
    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.3.8INN - Proposed INNValsartan
    D.3.9.1CAS number 137862-53-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with hypertension and metabolic syndrome (ATP III)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 4.0
    E.1.2Level LLT
    E.1.2Classification code 10052066
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that valsartan 320 mg has a positive effect on small, dense LDL subfractions (LDL 5+6) in hypertensive patients with metabolic syndrome after 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    To evaluate whether valsartan 320 mg has positive effects on further lipid subfractions and enzymes related to the lipoprotein metabolism. These parameters are: derived mean LDL-density, derived mean LDL-size, concentrations of cholesterol in VLDL, IDL, LDL, LDL-subfractions (LDL-1 to LDL-6), HDL, HDL-subfractions (HDL 2b, HDL 2a, and HDL 3), and PAF-AH activity.
    To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.
    To assess the safety and tolerability of valsartan 160-320mg.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Male or female outpatients ≥ 18 years of age at Visit 1
    2. MSSBP ≥ 140 mmHg and < 170 and/or MSDBP ≥ 90 mmHg and < 105 mmHg at Visit 2 for previously treated patients and at Visit 1 and 2 for previously untreated patients.
    3. Fasting triglycerides greater than or equal to 150 mg/dL (1.69 mmol/L) at V1
    4. Metabolic syndrome as defined by ATP III (involving one or more of the following) at Visit 1 (high triglycerides and elevated BP are mandatory in this trial):
    • Central/abdominal obesity as measured by waist circumference (Men > 102 cm; Women > 88 cm)
    • HDL cholesterol [Men < 40 mg/dL (1.04 mmol/L); Women < 50 mg/ dL (1.29 mmol/L)]
    • Fasting glucose greater than or equal to 110 mg/dL (6.1 mmol/L)
    5. Written informed consent to participate in this study prior to any study procedures
    E.4Principal exclusion criteria
    1. MSSBP ≥ 170 mmHg and/or MSDBP ≥ 105 mmHg at any time between Visit 1 and Visit 2
    2. Fasting plasma glucose ≥ 126 mg/dl at Visit 1
    3. Fasting LDL cholesterol ≥ 160 mg/dl, fasting triglycerides ≥ 600 mg/dl at Visit 1
    4. Inability to discontinue all antihypertensive medications safely for a period of three weeks prior to initiation of treatment
    5. Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1, use of probucol in the last 6 months prior to V1
    6. History of hypersensitivity to valsartan, inactive ingredients of valsartan capsules or to drugs with similar chemical structures
    7. A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease
    8. Known Keith-Wagener grade III or IV hypertensive retinopathy
    9. Second or third degree heart block without a pacemaker, concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, clinically significant valvular heart disease
    10. Heart failure NYHA II -IV
    11. Evidence of a secondary form of hypertension, to include coarctation of the aorta, hyperaldosteronism, Cushing’s disease, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease
    12. Evidence of hypercholesterolemia secondary to other causes. This includes, but is not restricted to: alcoholism, auto-immune disease, nephrotic syndrome, any viral or non-viral hepatitis clinically active within 12 months prior to Visit 1, obstructive hepatic or biliary disease, dys- or macroglobulinemia, multiple myeloma, glycogen storage disease, uncontrolled hypothyroidism or hyperthyroidism, chronic pancreatitis and porphyria
    13. Diabetes mellitus type I or II
    14. Major depression requiring pharmacolgical treatment
    15. Evidence of hepatic disease as determined by AST (SGOT) or ALT (SGPT) values > 3 x ULN at Visit 1
    16. A history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
    17. Evidence of renal impairment as determined by one of the followings: serum creatinine > 1.5 x ULN at Visit 1, a history of dialysis, or a history of nephrotic syndrome. If creatinine is found to be between 1.5 and 2 x UNL, a retest can be performed prior to initiation of treatment
    18. Any severe, life-threatening disease within the past five years
    19. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug including but not limited to any of the following:
    - History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection, gastric bypass, gastric stapling, or gastric banding
    - Currently active or active inflammatory bowel disease during the 12 months prior to Visit 1
    - Currently active gastritis, ulcers, or gastrointestinal/rectal bleeding or urinary tract obstruction regarded as clinically meaningful by the investigator
    20. Any surgical or medical condition which, at the discretion of the investigator, places the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period
    21. History of drug or alcohol abuse within the last 2 years
    22. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 halflives before enrollment, whichever is longer
    23. History of noncompliance with medical regimens, or patients unwilling to comply with the study protocol
    24. Persons directly involved in the execution of this protocol/study
    25. Inability to communicate and comply with all study requirements
    26. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
    27. 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 (> 5 mIU/ml).
    28. Women UNLESS they meet the following definition of post-menopausal: 24 months of natural (spontaneous) amenorrhea or 3 months post surgical bilateral oophorectomy with or without hysterectomy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary analysis will be the analysis of Apo B in LDL5+6 as reduction from baseline to study finalization.
    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 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 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.8.5The 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
    LPLV
    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 months0
    E.8.9.1In the Member State concerned days
    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 No
    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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 75
    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)
    Valsartan 320 mg is not approved yet for the treatment of hypertension in Germany. Valsartan 160 mg, Valsartan 160 mg /HCTZ 12.5 mg and Valsartan 160 mg /HCTZ 25 mg as well as various other antihypertensive drugs are available to be used as single agents or in combination. The investigator is free to decide about the subsequent treatment in the best interest of the patient.
    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 Decision2005-10-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-18
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