essential hypertension MedDRA version: 7.0 Level: LLT Classification code 10015488
Conditions
Interventions
Trade Name: Olmetec
Product Name: olmesartan medoxomil
Product Code: OM
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Olmesartan medoxomil
Current Sponsor code: CS-866
Concentration uni
Sponsors
Sankyo Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients at the age of 18 years or above with moderate to severe hypertension defined as a mean sitting sBP of not less than (NLT) 160 mmHg and a mean sitting dBP of NLT 100 mmHg not on antihypertensive medication and a mean 24-hour dBP assessed by 24h-ABPM of at least 84 mmHg and with at least 30% of daytime dBP readings above 90 mmHg at Visit 2 (at the end of the taper-off period) will enter Period I. Eligible patients who at Screening are already taking a stable dose of OM 20 mg or OM 40 mg for at least four weeks have to fulfil the following criteria before entering directly into Period I: previously suffered from moderate to severe hypertension (before first intake of OM 20 mg or OM 40 mg) mean sitting sBP NLT 140 mmHg and mean sitting dBP NLT 90 mmHg at Screening a mean 24-hour dBP of at least 80 mmHg assessed by 24h-ABPM and with at least 30% of daytime dBP readings over 85 mmHg. To be randomised to Period II, the mean 24-hour dBP assessed by 24h-ABPM must be at least 80 mmHg and at least 30% of the daytime dBP readings must be above 85 mmHg. Furthermore, the overall mean trough sitting dBP must be between 90 mmHg and 115 mmHg inclusive and the overall mean trough sitting sBP must be NLT 140 mmHg (at Visit 4/Week 8, conventional BP measurements). 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: - Female patients of childbearing potential must not be pregnant or lactating. Female patients of childbearing potential 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 cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases. - Patients having a history of the following within the last six months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke) or transient ischaemic attack. - Patients with clinically significant elevations of laboratory values at Screening. - Patients with secondary hypertension of any aetiology such as renal disease, pheochromocytoma or Cushing’s syndrome. - Patients with contraindication to amlodipine and/or olmesartan medoxomil.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate after eight weeks of double-blind treatment the additional antihypertensive efficacy in lowering trough sitting diastolic blood pressure (dBP) gained by adding AML 5 mg or 10 mg to the treatment regimen in patients with hypertension not adequately controlled on OM 20 mg alone assessed by conventional BP measurements.;Secondary Objective: 1. To evaluate after four weeks (Visit 5) & after eight weeks (Visit 6) of double-blind treatment the additional antihypertensive efficacy in trough sitting sBP lowering of the combinations of OM/AML compared to the monotherapy with OM 20 mg 2. To evaluate after four weeks (Visit 5) of double-blind treatment the additional antihypertensive efficacy in trough sitting dBP lowering of the combinations of OM/AML compared to the monotherapy with OM 20 mg. 3. To evaluate the additional antihypertensive efficacy in dBP and sBP lowering using 24h-ABPM. 4. To evaluate the number (%) of patients in each treatment group achieving BP goal (dBP < 90 mmHg & sBP < 140 mmHg, & dBP < 80 mmHg & sBP < 130 mmHg for diabetics) after four weeks (Visit 5) & after eight weeks of double-blind treatment (Visit 6) assessed. 5. To evaluate the safety and tolerability of the combinations of OM/AML versus monotherapy with OM 20 mg after eight weeks of double-blind treatment. ;Primary end point(s): The primary endpoint is the change from baseline (Week 8) to Week 16 (end of double-blind treatment) in trough sitting dBP. | — |
Countries
Germany, Spain
Outcome results
None listed