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

Bayer

Status and phase: Withdrawn; Phase 3

Conditions: Hypertension

Treatments: Drug: Candesartan Cilexetil; Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106); Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo; Drug: Candesartan matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02047019

14727

2012-004493-26 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:
• 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.
• Exclusion Criteria:
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

Candesartan

Active Comparator group

Description:

Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan 16 mg, Placebo combination A, Placebo combination B)

Treatment:

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

Drug: Candesartan Cilexetil

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

Nifedipine/Candesartan-30/16

Experimental group

Description:

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)

Treatment:

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

Drug: Candesartan matching placebo

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

Nifedipine/Candesartan-60/16

Experimental group

Description:

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)

Treatment:

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

Drug: Candesartan matching placebo

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo

Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)