Essential Hypertension MedDRA version: 20.0 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: BAY98-7106
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: NIFEDIPINE
CAS Number: 21829-25-4
Current Sponsor code
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 18 years or older are eligible. 2. At Visit 0, subjects not treated with antihypertensive medications are to have MSSBP = 160 mmHg and =65 years) yes F.1.3.1 Number of subjects for this age range 342
Exclusion criteria
Exclusion criteria: 1. MSSBP =200 mmHg and/or MSDBP =120 mmHg 2. MSDBP 3 x upper limit of normal (ULN) at Screening Visit - Renal insufficiency, defined as estimated glomerular filtration rate (estimated glomerular filtration rate [GFR]) of < 30 mL/min (see Section 7.6.2), 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 (see Section 6.9). 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 demonstrate the superior efficacy of the FDC of nifedipine GITS and candesartan cilexetil compared to nifedipine GITS monotherapy in subjects with essential hypertension not adequately controlled on nifedipine GITS alone, based on reduction of MSSBP.;Secondary Objective: 1. To demonstrate the efficacy of the FDCs of nifedipine GITS and candesartan cilexetil based on reduction of mean seated diastolic blood pressure (MSDBP), response rate, control rate. 2. To demonstrate the efficacy of the FDCs of Nifedipine GITS/ candesartan cilexetil based on reduction of mean diastolic blood pressure (DBP) and systolic blood pressure (SBP) on ABPM over a 24-h period, during both the daytime and night time. 2. To explore the safety and tolerability of the FDC treatments.;Primary end point(s): The primary efficacy variable will be change from baseline in MSSBP at Week 8. ;Timepoint(s) of evaluation of this end point: Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As a secondary endpoint, this study will evaluate the change from baseline in MSDBP, as well as predefined response and control criteria at week 8.;Timepoint(s) of evaluation of this end point: Week 8 | — |
Countries
China, Germany, Italy, Korea, Republic of, Taiwan, United States, Vietnam
Contacts
Public ContactClinical Trials Contact
Bayer AG
Outcome results
None listed