Essential Hypertension MedDRA version: 17.0 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: Nifedipine GITS/Candesartan cilexetil 30/8 mg
Product Code: BAY 98 7106
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NIFEDIPINE
CAS Number: 21829-25-4
Current Sponsor cod
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 18 years or older. 2. Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of = 160 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: 1. MSSBP = 200 mmHg and/or MSDBP = 120 mmHg 2. MSDBP 3 x ULN at Screening Visit - Renal insufficiency, defined as estimated glomerular filtration rate (estimated GFR) of < 30 mL/min or on hemodialysis 19. Investigational study participation with receipt of investigational study medication within the last month 20. Previous assignment to treatment in this study 21. Allergies or known intolerance to one of the investigational drugs/drug class or to one of their ingredients 22. Female subjects who are pregnant or lactating. 23. History of non-compliance, alcoholism, drug abuse or any other condition that in the opinion of the investigator will compromise successful completion of the study. 24. Subjects with pre-planned surgery during the course of the study 25. Inability to stop any of the medications listed in the prohibited concomitant medication list 26. Subjects who are on treatment with any drug approved for the treatment of hypertension, when prescribed for any reason other than control of blood pressure. 27. Close affiliation with the investigational site; eg. a close relative of the investigator, dependent person ( eg. employee or student of the investigational site)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the long-term safety and tolerability of FDC of nifedipine GITS / candesartan cilexetil (primarily the highest dose) once daily in subjects with moderate to severe essential hypertension.;Secondary Objective: The secondary objective is to evaluate the long-term efficacy of FDC nifedipine GITS / candesartan cilexetil (primarily the highest dose) once daily in subjects with moderate to severe essential hypertension.;Primary end point(s): Incidence of AEs and AEs of special interest, including the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as edema, headache, and flushing) ;Timepoint(s) of evaluation of this end point: At 28 and 52 weeks after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Laboratory evaluations -The change from baseline in MSSBP -The change from baseline in MSDBP -Control rate -Response rate ;Timepoint(s) of evaluation of this end point: At 28 and 52 weeks after randomization | — |
Countries
Belgium, Canada, Germany, Poland, United Kingdom, United States
Contacts
Public ContactClinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed