Subjects with severe essential hypertension (SBP between 150 mmHg and 200 mmHg AND DBP between 110 mmHg and 120 mmHg) who did not receive any antihypertensive treatment before will be included in the study MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: Blopress 16 mg Tabletten
Product Name: Candesartan Cilexetil 16 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: CANDESARTAN
CAS Number: 139481597
Current Sponsor code: CV 11974
Concent
Sponsors
Takeda Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Criteria for Inclusion: Subjects with severe essential hypertension (SBP between 150 mmHg and 200 mmHg AND DBP between 110 mmHg and 120 mmHg) who did not receive any antihypertensive treatment before and who gave informed consent will be included in the study. In females a negative pregnancy test and willingness to apply two independent methods of contraception will be additionally required. Patients will be included in the study if they met all of the following inclusion criteria: 1. Male and female outpatients of at least 18 years of age with a confirmed diagnosis of essential hypertension. 2.SBP between 150 mmHg and 200 mmHg AND DBP between 110 mmHg and 120 mmHg. Blood pressure will be measured in sitting position. 3. Patients did not receive any antihypertensive treatment so far. 4. Negative pregnancy test at baseline (visit 1) in females of childbearing potential. Male or female patients with reproductive potential must use an approved contraceptive method during study treatment evaluation (for details see Section 7.7) 5. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main Criteria for Exclusion: Subjects will not be included if they suffer from secondary hypertension, if they suffer from a severe concomitant disease, if they provide a contraindication for Candesartan cilexetil or Hydrochlorothiazide or if they are not eligible for other reasons (e.g., intake of psychotropic medication, addiction to alcohol or drugs, pregnancy, known or suspected non-compliance). Patients will be excluded from the study if they met any of the following exclusion criteria: 1. Known or suspected secondary hypertension or primary hyperaldosteronism. 2. Impaired renal function (creatinine concentration in serum =180 µmol/l for men respectively =140 µmol/l for women). 3. Severe hepatic impairment: ALAT and/or ASAT and/or ?-GT >3 x ULN and/or cholestasis. 4. Bilateral renal artery stenosis, solitary kidney or post-renal transplant status. 5. History of myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention or cerebral accident (stroke or transient ischaemic attack) within the last 6 months. 6. Diagnosis or suspicion of the following conditions: hypertrophic obstructive cardiomyopathy, angina pectoris, chronic heart failure, peripheral arterial occlusive disease, hypertensive retinopathy. 7. Haemodynamically relevant stenosis of the aortic or mitral valve. 8. Clinically relevant and refractory hypo- (5.5 mval/l). 9. Uncorrected volume or sodium depletion. 10. Gout or relevant hyperuricaemia. 11. Known intolerance/hypersensitivity to Candesartan cilexetil or Hydrochlorothiazide. 12. Known galactose intolerance, lactase deficiency or glucose-galactose malabsorption. 13. Patients taking psychotropic medication or being addicted to alcohol or drugs. 14. Pregnant or breast feeding women. 15. Known or suspected inability or unwillingness to abide by the requirements of the study protocol. 16. Known or suspected non-compliance regarding intake of the study medication. 17. Subject has participated in another trial of an investigational drug or a medical device within the last 30 days or is currently participating in another trial of an investigational drug or a medical device. 18. Personnel involved in the planning or conduct of the study 19. Withdrawal of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Change in SBP and DBP from visit 1 to visit 5;Secondary Objective: • Percentage of overall responders, i.e., percentage of patients showing a decrease in SBP to <140 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to <90 mmHg and/or a decrease of DBP by at least 10 mmHg. • Percentage of diabetics turned out to be responders, i.e., showing a decrease in SBP to <130 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to <80 mmHg and/or a decrease of DBP by at least 10 mmHg. • Change in pulse rate from visit 1 to visit 5. • Change of SBP and DBP during the course of the study. • Change of pulse rate during the course of the study. ;Primary end point(s): The primary endpoint for this study is change in SBP and DBP from visit 1 to visit 5. Key secondary endpoints for this study are: • Percentage of overall responders, i.e., percentage of patients showing a decrease in SBP to <140 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to <90 mmHg and/or a decrease of DBP by at least 10 mmHg. • Percentage of diabetics turned out to be responders, i.e., showing a decrease in SBP to <130 mmHg and/or a decrease of SBP by at least 20 mmHg AND a decrease in DBP to <80 mmHg and/or a decrease of DBP by at least 10 mmHg. • Change in pulse rate from visit 1 to visit 5. • Change of SBP and DBP during the course of the study. • Change of pulse rate during the course of the study.Further efficacy criteria may be specified in the statistical analysis plan (SAP). | — |
Countries
Germany
Outcome results
None listed