Clinical Study to Evaluate the Efficacy and Safety of the Combination Therapy Candesartan Cilexetil 32 mg plus Hydrochlorothiazide 25 mg in Patients with Severe Hypertension

Takeda Pharma GmbH0 sites100 target enrollmentJuly 13, 2009

Overview

Phase: N/A
Intervention: Not specified
Conditions: 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
Sponsor: Takeda Pharma GmbH
Enrollment: 100
Status: Active, Not Recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

July 13, 2009

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Takeda Pharma GmbH

•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:

•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.