Clinical trial NCT02047019: Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hypertension
Keywords: Drug combination
Nifedipine GITS
Candesartan Cilexetil
Hypertension
Combination therapy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Change in mean seated systolic blood pressure (MSSBP).
timeFrame: From baseline to treatment week 8
Secondary outcomes:
measure: Change in mean seated diastolic blood pressure (MSDBP).
timeFrame: From baseline to treatment week 8
measure: Blood pressure Response Rate
timeFrame: Treatment week 8
measure: Blood pressure Control Rate
timeFrame: Treatment week 8
measure: Mean change in systolic blood pressure and diastolic blood pressure in ambulatory blood pressure monitoring over 24 hours.
timeFrame: Treatment week 8
measure: Number of participants with adverse events as a measure of safety and tolerability.
timeFrame: Treatment week 8
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Fondazione Università G.D'Annunzio
state: Abruzzo
city: Bologna
country: Italy
facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi
state: Emilia-Romagna
city: Udine
country: Italy
facility: AAS 3 Friuli Alto Medio Collin
state: Friuli-Venezia Giulia
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
state: Lombardia
city: Isernia
country: Italy
facility: IRCCS Ist Neurologico Mediterraneo
state: Molise
city: Sassari
country: Italy
facility: A.O.U. di Sassari
state: Sardegna
city: Pisa
country: Italy
facility: A.O.U. Pisana
state: Toscana
city: Treviso
country: Italy
facility: AULSS 07 Pieve Soligo
state: Veneto
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: