stop_circleTerminated/Withdrawn

Hypertension

Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects with Essential Hypertension Inadequately Controlled on Candesartan Cilexetil

Trial purpose

This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate control of blood pressure with candesartane alone.
Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five weeks of the study to assess blood pressure control with candesartan given alone.
Patients with an insufficient therapeutic response to candesartan alone (defined by mean seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last eight weeks.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - :
    - Male and female subjects 18 years or older are eligible.
    - At Visit 0, subjects not treated with antihypertensive medications are to have MSSBP (mean seated systolic blood pressure) of >/= 160 mmHg and < 200 mmHg, and 24 hours MASBP (mean ambulatory systolic blood pressure) >/= 130 mmHg; those subjects treated with antihypertensive medication are to have MSSBP >/= 150 mmHg and < 200 mmHg as measured by a calibrated electronic BP measuring device
    - At Visit 3,subject must have MSSBP >/= 140 mmHg before randomization.
    - Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active. This applies since signing of the IC (informed consent)form until the last study drug administration.

    -
  • - Mean seated systolic blood pressure (MSSBP) >/= 200 mmHg and/or mean seated diastolic blood pressure (MSDBP) >/= 120 mm/Hg
    - Mean seated diastolic blood pressure (MSDBP) < 60 mm/Hg
    - Differences greater than 20 mmHg for systolic blood pressure (SBP) and 10 mmHg for diastolic blood pressure (DBP) are present on 3 consecutive blood pressure readings at visit 0
    - Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
    - Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA]) within the previous 12 months
    - History of hypertensive retinopathy – known Keith-Wagener Grade III or IV. Any history of heart failure, New York Heart Association (NYHA) classification III or IV
    - Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
    - Clinically significant cardiac valvular disease
    - Subjects with an aortic aneurysm that, in the opinion of the investigator, will be unsuitable to be enrolled in the study.
    - Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by glycosylated hemoglobin HbA1C of greater than 9% on visit 0

Trial summary

Enrollment Goal
0
Trial Dates
December 2017 - December 2019
Phase
Phase 3
Could I Receive a placebo
No
Products
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Fondazione Salvatore MaugeriPavia, 27100, Italy
Terminated
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Terminated
Fondazione Università G.D'AnnunzioChieti, 66100, Italy
Terminated
AULSS 07 Pieve SoligoTreviso, 31029, Italy
Terminated
A.O.U. di SassariSassari, 07100, Italy
Terminated
IRCCS Ist Neurologico MediterraneoIsernia, 86077, Italy
Terminated
AAS 3 Friuli Alto Medio CollinUdine, 33038, Italy
Terminated
A.O.U. PisanaPisa, 56126, Italy
Withdrawn
Crouch Oak Family PracticeAddlestone, KT15 2BH, United Kingdom
Withdrawn
Adcroft SurgeryTrowbridge, BA14 8QA, United Kingdom
Withdrawn
Cape Cornwall SurgeryPenzance, TR19 7HX, United Kingdom
Withdrawn
Cairn Medical PracticeInverness, IV2 4AG, United Kingdom
Withdrawn
Rowden SurgeryChippenham, SN15 2SB, United Kingdom
Withdrawn
Sherbourne Medical CentreLeamington Spa, CV32 4RA, United Kingdom
Withdrawn
Brannel SurgerySt Austell, PL26 7RL, United Kingdom
Withdrawn
Eastleigh SurgeryWestbury, BA13 3JD, United Kingdom
Withdrawn
Oldfield SurgeryBath, BA2 3HT, United Kingdom
Withdrawn
Bradford Road Medical CentreTrowbridge, BA14 9AR, United Kingdom
Withdrawn
The Alverton PracticePenzance, TR18 4JH, United Kingdom
Withdrawn
Saules family medicine centerKaunas, LT-49449, Lithuania
Withdrawn
UAB "Klinikiniai sprendimai" KaunasKaunas, LT-49387, Lithuania
Withdrawn
Medizinische Hochschule Hannover (MHH)Hannover, 30625, Germany
Withdrawn
Praxis Dr. med. Julia ChevtsKarlsruhe, 76199, Germany
Withdrawn
Gem-Praxis Drs. Zühlke, Faghih, FriedrichsEssen, 45355, Germany
Withdrawn
Praxis Hr. Dr. Josef GroßkopfWallerfing, 94574, Germany
Withdrawn
Praxis Hr. Dr. R. SchätzlGroßheirath-Rossach, 96269, Germany
Withdrawn
Praxis Hr. Dr. Ernest SchellNürnberg, 90402, Germany
Withdrawn
Praxis Hr. Dr. H. SchneiderMeßkirch, 88605, Germany
Withdrawn
Advance Clinical ResearchSt. Louis, 63128, United States
Withdrawn
Paragon Research CenterSan Antonio, 78205, United States
Withdrawn
New Orleans Center for Clinical Research/Volunteer Res GroupKnoxville, 37920, United States
Withdrawn
PMG Research of Salisbury, LLCSalisbury, 28144, United States
Withdrawn
PMG Research of CharlestonMt. Pleasant, 29464, United States
Withdrawn
University of South AlabamaMobile, 36617, United States
Withdrawn
PMG Research of CharlotteCharlotte, 28209, United States
Withdrawn
Clinical Trials ResearchLincoln, 95648, United States
Withdrawn
Associated Pharmaceutical Research CenterBuena Park, 90620-3888, United States
Withdrawn
Sierra Clinical ResearchRoseville, 95661-2847, United States
Withdrawn
Orange County Research CenterTustin, 92780, United States
Withdrawn
Texas Center for Drug DevelopmentHouston, 77081, United States
Withdrawn
Advance Clinical ResearchSt. Louis, 63128, United States
Withdrawn
Hospital Clínico Universitario San CecilioGranada, 18012, Spain
Withdrawn
CAP Hostalets de BalenyàHostalets de Balenyà, 08550, Spain
Withdrawn
Centro de Salud Quart de PobletQuart de Poblet, Spain
Withdrawn
Hospital Universitario "La Paz"Madrid, 28046, Spain
Withdrawn
Cabinet Médical - Desormeaux - ErigneMURS ERIGNE, 49610, France
Withdrawn
Cabinet Médical - Martin - BourgesBOURGES, 18000, France
Withdrawn
Cabinet Médical du Dr COUFFINLA CHAPELLE sur ERDRE, 44240, France
Withdrawn
Cabinet Médical - Beaurepaire - VihiersVIHIERS, 49310, France
Withdrawn
Hôpital Purpan - ToulouseTOULOUSE, 31059, France
Withdrawn
Centro de Salud La OrdenHuelva, 21003, Spain
Withdrawn
Centro de Salud PetrerPetrer, 03610, Spain
Withdrawn
Hospital Miguel ServetZaragoza, 50009, Spain
Withdrawn
Sanatorio BritánicoRosario, 2000, Argentina
Withdrawn
Centro de Investigaciones ClínicasBuenos Aires, C1425DES, Argentina
Withdrawn
Instituto Médico Especializado (IME)Buenos Aires, 1405, Argentina
Withdrawn
CENUDIABBuenos Aires, C1440AAD, Argentina
Withdrawn
UAB "Mano seimos gydytojas"Klaipeda, LT-94231, Lithuania
Withdrawn
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikKaunas, LT-50161, Lithuania
Withdrawn
UAB "Klinikiniai sprendimai" AlytusAlytus, LT-62381, Lithuania
Withdrawn
VAKK Ltd. A. Kildas Private ClinicKaunas, LT-51028, Lithuania
Withdrawn
Poliklinika LIPA centrumPraha 13, 158 00, Czech Republic
Withdrawn
Institut Klinicke a Experimentalni Mediciny IKEMPraha 4, 140 21, Czech Republic
Withdrawn
MONSE, spol.s.r.o.Praha 6, 169 00, Czech Republic
Withdrawn
Prakticky lekar pro dospelePraha-Michle, 141 00, Czech Republic
Withdrawn
kardiologicka ambulancePraha 1, 110 00, Czech Republic
Withdrawn
MEDISCAN group, s.r.o., Centrum klinickych hodnoceniPraha 11, 148 00, Czech Republic
Withdrawn
Kardiologicka ordinace MU Dr. Zdenek Lorenc s.r.o.Plzen, 301 00, Czech Republic
Withdrawn
MATMED s.r.o.Hodonin, 695 01, Czech Republic
Withdrawn
DIKa centrum s.r.o.Havirov-Mesto, 736 01, Czech Republic
Withdrawn
Interni ambulanceJicin, 506 01, Czech Republic
Withdrawn
Istanbul Universitesi Istanbul Tip FakultesiIstanbul, 34093, Turkey
Withdrawn
Goztepe Training and Research HospitalISTANBUL, 34730, Turkey
Withdrawn
Kocaeli Universitesi Tip FakultesiKocaeli, 41380, Turkey
Withdrawn
Cumhuriyet University Medical FacultySIVAS, 58140, Turkey
Withdrawn
Gulhane Military Academy of MedicineANKARA, 06010, Turkey
Withdrawn
Centro Médico Privado CEMAICCórdoba, 5008, Argentina
Withdrawn
City Clinical Hospital #31Moscow, 119415, Russia
Withdrawn
Medical Exercises Dispensary of Krasnogvardeysky regionSt. Petersburg, 195112, Russia
Withdrawn
St Petersburg Military Medical AcademySt Petersburg, 198013, Russia
Withdrawn
North-West Federal Medical Research CenterSt. Petersburg, 197341, Russia
Withdrawn
HygeiaHASSELT, 3500, Belgium
Withdrawn
Balthazar BallardNATOYE, 5360, Belgium
Withdrawn
Luc ErpicumTAVIER, 1401, Belgium
Withdrawn
Véronique MoreauBAULERS, 4163, Belgium
Withdrawn
BVBA Luc CapiauWetteren, 9230, Belgium
Withdrawn
Huisartsenpraktijk De RegenboogDeurne, 2100, Belgium
Withdrawn
Norbert Van MuldersMOORSEL, 9310, Belgium
Withdrawn
Bart Van EsscheSTEENOKKERZEEL, 1820, Belgium
Withdrawn
Dr J MortelmansHAM, 3545, Belgium
Withdrawn
Centre Medical Acadie, Inc.Montreal, H4N 2W2, Canada
Withdrawn
London Road Diagnostic CentreSarnia, N7T 4X3, Canada
Withdrawn
Family First Health CentreOrleans, K4A 5E6, Canada
Withdrawn
Moran Medical CentreCollingwood, L9Y 1W3, Canada

Primary Outcome

  • Change in mean seated systolic blood pressure (MSSBP).
    date_rangeTime Frame:
    From baseline to treatment week 8
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change in mean seated diastolic blood pressure (MSDBP).
    date_rangeTime Frame:
    From baseline to treatment week 8
    enhanced_encryption
    Safety Issue:
    No
  • Blood pressure Response Rate
    Response rate is defined as the percentage of subjects achieving a systolic blood pressure (SBP) response (MSSBP of < 140 mmHg or a reduction of MSSBP of > 20 mm Hg from baseline value), or a diastolic blood pressure (DBP) response (i.e. MSDBP of < 90 mmHg or a reduction of MSDBP of > 10 mm Hg from baseline value) after 8 weeks treatment.
    date_rangeTime Frame:
    Treatment week 8
    enhanced_encryption
    Safety Issue:
    No
  • Blood pressure Control Rate
    Control rate is the percentage of subjects that reach the predetermined blood pressure(BP) target < 140/90 mmHg. In addition, the percentage of subjects that reach the predetermined BP target < 140/90 mmHg for subjects without diabetes or chronic renal disorder(baseline estimated glomerular filtration rate(GFR) < 60 mL/min); <130/80 mmHg for subjects with diabetes or chronic renal disorder will be provided as well.
    date_rangeTime Frame:
    Treatment week 8
    enhanced_encryption
    Safety Issue:
    No
  • Mean change in systolic blood pressure and diastolic blood pressure in ambulatory blood pressure monitoring over 24 hours.
    date_rangeTime Frame:
    Treatment week 8
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events as a measure of safety and tolerability.
    date_rangeTime Frame:
    Treatment week 8
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Multicenter, Randomized, Double-Blind, Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination Taken Orally for 8 Weeks in Adult Subjects with Essential Hypertension Who Are Inadequately Controlled on 16 mg Candesartan Cilexetil Monotherapy
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3