stop_circleTerminated/Withdrawn
Hypertension
Bayer Identifier:
14727
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
BothAge
18 - N/ATrial summary
Enrollment Goal
0Trial Dates
December 2017 - December 2019Phase
Phase 3Could I Receive a placebo
NoProducts
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Fondazione Salvatore Maugeri | Pavia, 27100, Italy |
Terminated | A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna, 40138, Italy |
Terminated | Fondazione Università G.D'Annunzio | Chieti, 66100, Italy |
Terminated | AULSS 07 Pieve Soligo | Treviso, 31029, Italy |
Terminated | A.O.U. di Sassari | Sassari, 07100, Italy |
Terminated | IRCCS Ist Neurologico Mediterraneo | Isernia, 86077, Italy |
Terminated | AAS 3 Friuli Alto Medio Collin | Udine, 33038, Italy |
Terminated | A.O.U. Pisana | Pisa, 56126, Italy |
Withdrawn | Crouch Oak Family Practice | Addlestone, KT15 2BH, United Kingdom |
Withdrawn | Adcroft Surgery | Trowbridge, BA14 8QA, United Kingdom |
Withdrawn | Cape Cornwall Surgery | Penzance, TR19 7HX, United Kingdom |
Withdrawn | Cairn Medical Practice | Inverness, IV2 4AG, United Kingdom |
Withdrawn | Rowden Surgery | Chippenham, SN15 2SB, United Kingdom |
Withdrawn | Sherbourne Medical Centre | Leamington Spa, CV32 4RA, United Kingdom |
Withdrawn | Brannel Surgery | St Austell, PL26 7RL, United Kingdom |
Withdrawn | Eastleigh Surgery | Westbury, BA13 3JD, United Kingdom |
Withdrawn | Oldfield Surgery | Bath, BA2 3HT, United Kingdom |
Withdrawn | Bradford Road Medical Centre | Trowbridge, BA14 9AR, United Kingdom |
Withdrawn | The Alverton Practice | Penzance, TR18 4JH, United Kingdom |
Withdrawn | Saules family medicine center | Kaunas, LT-49449, Lithuania |
Withdrawn | UAB "Klinikiniai sprendimai" Kaunas | Kaunas, LT-49387, Lithuania |
Withdrawn | Medizinische Hochschule Hannover (MHH) | Hannover, 30625, Germany |
Withdrawn | Praxis Dr. med. Julia Chevts | Karlsruhe, 76199, Germany |
Withdrawn | Gem-Praxis Drs. Zühlke, Faghih, Friedrichs | Essen, 45355, Germany |
Withdrawn | Praxis Hr. Dr. Josef Großkopf | Wallerfing, 94574, Germany |
Withdrawn | Praxis Hr. Dr. R. Schätzl | Großheirath-Rossach, 96269, Germany |
Withdrawn | Praxis Hr. Dr. Ernest Schell | Nürnberg, 90402, Germany |
Withdrawn | Praxis Hr. Dr. H. Schneider | Meßkirch, 88605, Germany |
Withdrawn | Advance Clinical Research | St. Louis, 63128, United States |
Withdrawn | Paragon Research Center | San Antonio, 78205, United States |
Withdrawn | New Orleans Center for Clinical Research/Volunteer Res Group | Knoxville, 37920, United States |
Withdrawn | PMG Research of Salisbury, LLC | Salisbury, 28144, United States |
Withdrawn | PMG Research of Charleston | Mt. Pleasant, 29464, United States |
Withdrawn | University of South Alabama | Mobile, 36617, United States |
Withdrawn | PMG Research of Charlotte | Charlotte, 28209, United States |
Withdrawn | Clinical Trials Research | Lincoln, 95648, United States |
Withdrawn | Associated Pharmaceutical Research Center | Buena Park, 90620-3888, United States |
Withdrawn | Sierra Clinical Research | Roseville, 95661-2847, United States |
Withdrawn | Orange County Research Center | Tustin, 92780, United States |
Withdrawn | Texas Center for Drug Development | Houston, 77081, United States |
Withdrawn | Advance Clinical Research | St. Louis, 63128, United States |
Withdrawn | Hospital Clínico Universitario San Cecilio | Granada, 18012, Spain |
Withdrawn | CAP Hostalets de Balenyà | Hostalets de Balenyà, 08550, Spain |
Withdrawn | Centro de Salud Quart de Poblet | Quart de Poblet, Spain |
Withdrawn | Hospital Universitario "La Paz" | Madrid, 28046, Spain |
Withdrawn | Cabinet Médical - Desormeaux - Erigne | MURS ERIGNE, 49610, France |
Withdrawn | Cabinet Médical - Martin - Bourges | BOURGES, 18000, France |
Withdrawn | Cabinet Médical du Dr COUFFIN | LA CHAPELLE sur ERDRE, 44240, France |
Withdrawn | Cabinet Médical - Beaurepaire - Vihiers | VIHIERS, 49310, France |
Withdrawn | Hôpital Purpan - Toulouse | TOULOUSE, 31059, France |
Withdrawn | Centro de Salud La Orden | Huelva, 21003, Spain |
Withdrawn | Centro de Salud Petrer | Petrer, 03610, Spain |
Withdrawn | Hospital Miguel Servet | Zaragoza, 50009, Spain |
Withdrawn | Sanatorio Británico | Rosario, 2000, Argentina |
Withdrawn | Centro de Investigaciones Clínicas | Buenos Aires, C1425DES, Argentina |
Withdrawn | Instituto Médico Especializado (IME) | Buenos Aires, 1405, Argentina |
Withdrawn | CENUDIAB | Buenos Aires, C1440AAD, Argentina |
Withdrawn | UAB "Mano seimos gydytojas" | Klaipeda, LT-94231, Lithuania |
Withdrawn | Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik | Kaunas, LT-50161, Lithuania |
Withdrawn | UAB "Klinikiniai sprendimai" Alytus | Alytus, LT-62381, Lithuania |
Withdrawn | VAKK Ltd. A. Kildas Private Clinic | Kaunas, LT-51028, Lithuania |
Withdrawn | Poliklinika LIPA centrum | Praha 13, 158 00, Czech Republic |
Withdrawn | Institut Klinicke a Experimentalni Mediciny IKEM | Praha 4, 140 21, Czech Republic |
Withdrawn | MONSE, spol.s.r.o. | Praha 6, 169 00, Czech Republic |
Withdrawn | Prakticky lekar pro dospele | Praha-Michle, 141 00, Czech Republic |
Withdrawn | kardiologicka ambulance | Praha 1, 110 00, Czech Republic |
Withdrawn | MEDISCAN group, s.r.o., Centrum klinickych hodnoceni | Praha 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 ambulance | Jicin, 506 01, Czech Republic |
Withdrawn | Istanbul Universitesi Istanbul Tip Fakultesi | Istanbul, 34093, Turkey |
Withdrawn | Goztepe Training and Research Hospital | ISTANBUL, 34730, Turkey |
Withdrawn | Kocaeli Universitesi Tip Fakultesi | Kocaeli, 41380, Turkey |
Withdrawn | Cumhuriyet University Medical Faculty | SIVAS, 58140, Turkey |
Withdrawn | Gulhane Military Academy of Medicine | ANKARA, 06010, Turkey |
Withdrawn | Centro Médico Privado CEMAIC | Córdoba, 5008, Argentina |
Withdrawn | City Clinical Hospital #31 | Moscow, 119415, Russia |
Withdrawn | Medical Exercises Dispensary of Krasnogvardeysky region | St. Petersburg, 195112, Russia |
Withdrawn | St Petersburg Military Medical Academy | St Petersburg, 198013, Russia |
Withdrawn | North-West Federal Medical Research Center | St. Petersburg, 197341, Russia |
Withdrawn | Hygeia | HASSELT, 3500, Belgium |
Withdrawn | Balthazar Ballard | NATOYE, 5360, Belgium |
Withdrawn | Luc Erpicum | TAVIER, 1401, Belgium |
Withdrawn | Véronique Moreau | BAULERS, 4163, Belgium |
Withdrawn | BVBA Luc Capiau | Wetteren, 9230, Belgium |
Withdrawn | Huisartsenpraktijk De Regenboog | Deurne, 2100, Belgium |
Withdrawn | Norbert Van Mulders | MOORSEL, 9310, Belgium |
Withdrawn | Bart Van Essche | STEENOKKERZEEL, 1820, Belgium |
Withdrawn | Dr J Mortelmans | HAM, 3545, Belgium |
Withdrawn | Centre Medical Acadie, Inc. | Montreal, H4N 2W2, Canada |
Withdrawn | London Road Diagnostic Centre | Sarnia, N7T 4X3, Canada |
Withdrawn | Family First Health Centre | Orleans, K4A 5E6, Canada |
Withdrawn | Moran Medical Centre | Collingwood, L9Y 1W3, Canada |
Primary Outcome
- Change in mean seated systolic blood pressure (MSSBP).date_rangeTime Frame:From baseline to treatment week 8enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Change in mean seated diastolic blood pressure (MSDBP).date_rangeTime Frame:From baseline to treatment week 8enhanced_encryptionNoSafety Issue:
- Blood pressure Response RateResponse 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 8enhanced_encryptionNoSafety Issue:
- Blood pressure Control RateControl 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 8enhanced_encryptionNoSafety Issue:
- Mean change in systolic blood pressure and diastolic blood pressure in ambulatory blood pressure monitoring over 24 hours.date_rangeTime Frame:Treatment week 8enhanced_encryptionNoSafety Issue:
- Number of participants with adverse events as a measure of safety and tolerability.date_rangeTime Frame:Treatment week 8enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
3