Mild to moderate hypertension
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Pharmaceutical Form: Film-coated tablet
Pharmaceutical
Sponsors
Daiichi SankyoGmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients age = 18 years with mild to moderate hypertension. Pre-treated patients with normal or elevated blood pressure are eligible to participate if their pre-treatment can be withdrawn. At the end of the placebo run-in period sitting sBP =140 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Female patients of childbearing potential must not be pregnant or lactating and must be using adequate contraception. Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/ oncological, neurological and psychiatric diseases. Patients within the last 6 months having a history of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, or transient ischemic attack. Patients with clinically significant elevations in laboratory values at Screening Visit. Patients with secondary hypertension of any etiology, such as renal disease, pheocromocytoma, or Cushing’s syndrome. Patients with contra-indications for olmesartan medoxomil, hydrochlorothiazide, and/or amlodipine besylate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the Subjects Treated to Target (STTT) rate overall and on each treatment combination step. STTT are defined as patients with mild to moderate hypertension achieving target blood pressure. Target blood pressure is defined as mean sitting systolic BP at trough of = 130 mmHg and mean sitting diastolic BP = 85 mmHg for non-diabetic patients or mean sitting systolic BP at trough of < 130 mmHg and mean sitting diastolic BP < 80 mmHg for diabetic patients. ;Secondary Objective: 1. Influence of prognostic factors for the need of a combination therapy. 2. Effect of OLM monotherapy and the add-on treatment algorithm overall and on each treatment combination step in terms of the percentage of patients achieving a mean sitting systolic BP at trough of < 140 mmHg and mean sitting diastolic BP < 90 mmHg for non-diabetic patients or a mean sitting systolic BP at trough of < 130 mmHg and mean sitting diastolic BP < 80 mmHg for diabetic patients. 3. Effect of OLM monotherapy and the add-on treatment algorithm in terms of change of mean sitting sBP and dBP versus baseline at each visit. 4. Effect of OLM monotherapy and the add-on treatment algorithm in terms of a decrease of = 10 mmHg in mean sitting dBP or a mean sitting dBP of < 90 mmHg at trough at each visit. 5. Safety and tolerability of OLM monotherapy and the add-on treatment algorithm consisting of HCTZ and AML after a maximum of 20 weeks of active treatment. ;Primary end point(s): Reaching Target blood pressure. Target blood pressure is defined as mean sitting systolic BP at trough of = 130 mmHg and mean sitting diastolic BP = 85 mmHg for non-diabetic patients or mean sitting systolic BP at trough of < 130 mmHg and mean sitting diastolic BP < 80 mmHg for diabetic patients. | — |
Countries
Austria, Belgium, Germany, Portugal, United Kingdom
Outcome results
None listed