essential hypertension MedDRA version: 7.0 Level: LLT Classification code 10015488
Conditions
Interventions
Product Name: Olmesartan
Product Code: OM
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Olmesartan medoxomil
Current Sponsor code: CS-866
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Daiichi Sankyo Europe GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients aged 18 years or older. Patients with moderate to severe hypertension defined as mean sitting sBP not less than (NLT)160 mmHg, mean sitting dBP NLT 100 mmHg and a mean 24-hour dBP, assessed by 24hour-ABPM, of at least 84 mmHg and with at least 30% of daytime dBP readings over 90 mmHg at Visit 2 (i.e. prior to monotherapy treatment) will enter Period I. Eligible patients who at Screening are already taking a stable dose of AML 5 mg or AML 10 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 AML 5 mg or AML 10 mg) - mean sitting sBP NLT 140 mmHg and mean sitting dBP NLT 90 mmHg at Screening - a mean 24-hour dBP, assessed by 24hour-ABPM, of at least 80 mmHg and with at least 30% of daytime dBP readings over 85 mmHg (at Visit 2). To be randomised, the mean sitting trough dBP must be between 90 and 115 mmHg inclusive and the mean sitting trough systolic blood pressure (sPB) must be NLT 140 mmHg (at Visit 4, conventional BP measurement). Furthermore, the mean 24-hour dBP, assessed by 24hour-ABPM, must be at least 80 mmHg and at least 30% of daytime dBP readings must be over 85 mmHg on monotherapy with amlodipine 5 mg. 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. - Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s), including cerebrovascular, cardiovascular, renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/onco- logical, neurological and psychiatric diseases. - Patients with poorly controlled diabetes mellitus. - Patients having a history of the following within the last six months: myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, heart failure, cerebrovascular accident, congestive heart failure, or transient ischaemic attack. - Patients with clinically significant elevations in laboratory values at Screening. - Patients with secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or Cushing’s syndrome. - Patients with contraindications to olmesartan medoxomil, amlodipine besilate and/or hydrochloro-thiazide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the additional antihypertensive efficacy in lowering sitting trough diastolic blood pressure (dBP) gained by adding OM 10, 20 or 40 mg to the treatment regimen in patients with moderate to severe hypertension not adequately controlled on AML 5 mg alone assessed by conventional BP measurements after eight weeks of double-blind treatment.;Secondary Objective: 1. Mean change (difference) from baseline (Week 8) to Weeks 12, 16, 20 and 24 in sitting trough sBP. 2. Mean change (difference) from baseline (Week 8) to Weeks 12, 20 and 24 in sitting trough dBP. 3. Mean change (difference) from baseline (Week 8) to week 16 and 24 in daytime, nighttime, and 24-hours dBP and sBP, assessed by 24hour-ABPM. 4. Number (%) of patients achieving blood pressure goal (dBP < 90 mmHg and sBP < 140 mmHg, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics) after Period II and III . 5. Evaluation of the clinical and laboratory adverse event profile for various combinations of AML/OM compared to AML 5 mg monotherapy after 8 weeks of double-blind treatment and after the additional eight-week up-titration period. 6. Evaluation of AML/OM with regard to the clinical adverse experience profile after long-term treatment. ;Primary end point(s): Mean change (difference) from baseline (start of double-blind treatment after an 8-week monotherapy phase) to the end of the 8-week double-blind treatment (Week 16) in sitting trough dBP, assessed by conventional BP measurement. | — |
Countries
Belgium, Finland, Germany, Italy, United Kingdom
Outcome results
None listed