Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil
NCT ID: NCT02047019
Last Updated: 2017-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2017-12-01
2019-12-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Candesartan
Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan 16 mg, Placebo combination A, Placebo combination B)
Candesartan Cilexetil
Candesartan Cilexetil, 16 mg, capsule, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo, tablet, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16mg matching placebo, tablet, orally, once daily
Nifedipine/Candesartan-30/16
Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan placebo, Placebo combination A, Combination nifedipine / candesartan 30/16 mg)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 30/16 mg, tablet, orally, once daily
Candesartan matching placebo
Candesartan matching placebo, capsule, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16mg matching placebo, tablet, orally, once daily
Nifedipine/Candesartan-60/16
Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan placebo, Placebo combination B, Combination nifedipine / candesartan 60/16 mg)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16 mg, tablet, orally, once daily
Candesartan matching placebo
Candesartan matching placebo, capsule, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo, tablet, orally, once daily
Interventions
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Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 30/16 mg, tablet, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16 mg, tablet, orally, once daily
Candesartan Cilexetil
Candesartan Cilexetil, 16 mg, capsule, orally, once daily
Candesartan matching placebo
Candesartan matching placebo, capsule, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo, tablet, orally, once daily
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16mg matching placebo, tablet, orally, once daily
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Fondazione Università G.D'Annunzio
Chieti, Abruzzo, Italy
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, Italy
AAS 3 Friuli Alto Medio Collin
Udine, Friuli Venezia Giulia, Italy
Fondazione Salvatore Maugeri
Pavia, Lombardy, Italy
IRCCS Ist Neurologico Mediterraneo
Isernia, Molise, Italy
A.O.U. di Sassari
Sassari, Sardinia, Italy
A.O.U. Pisana
Pisa, Tuscany, Italy
AULSS 07 Pieve Soligo
Treviso, Veneto, Italy
Countries
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Other Identifiers
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2012-004493-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14727
Identifier Type: -
Identifier Source: org_study_id
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