Essential Hypertension MedDRA version: 8.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Sponsors
DAIICHI SANKYO EUROPE GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female Europeans aged 18 years or older with moderate to severe HTN, defined as follows (conventional BP measurement): •Mean trough sitting BP of = 160/100 mmHg, at Screening in patients not currently on antihypertensive medication. •Mean trough sitting BP of = 140/90 mmHg at Screening in patients currently on antihypertensive medication. •Mean trough sitting BP of = 160/100 mmHg in newly diagnosed patients or at the end of the taper off period in patients who have discontinued their previous antihypertensive medication, prior to entering open label treatment (Period I). •Mean trough sitting BP of = 140/90 mmHg prior to entering open label treatment (Period I) in patients on a stable dose of OM 20 mg or 40 mg for at least four weeks. •A mean 24-hour dBP of at least 80 mmHg with at least 30% of daytime dBP readings over 85 mmHg for patients on stable OM 20 or 40 mg. •A mean 24-hour dBP of at least 85 mmHg with at least 30% of daytime dBP readings over 90 mmHg, for newly diagnosed patients or treated patients at the end of the taper-off period. 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 or planning to become pregnant during the trial period. 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 study medication, 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, heart failure, hypertensive encephalopathy, cerebrovascular accident (stroke) or transient ischaemic attack. •Patients with clinically significant abnormal laboratory values at Screening. •Patients with secondary HTN of any aetiology such as renal disease, pheochromocytoma, or Cushing’s syndrome. •Patients with contraindication to HCTZ and/or OM. •Patients with mean sitting BP exceeding 200/120 mmHg (at Screening, Visit 1 or Visit 2), a mean 24-hour dBP exceeding 109 mmHg (at Visit 2) or bradycardia (< 50 beats/min at rest documented by mean radial PR or ECG, at Screening, Visit 1 or Visit 2).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy in lowering mean trough sitting diastolic blood pressure (dBP) between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, assessed by conventional BP measurements, after eight weeks of double blind treatment, as compared to baseline.;Secondary Objective: To evaluate the efficacy of OM/HCTZ 20/25 mg vs. 40/25mg, by measuring the change in mean trough sitting diastolic blood pressure (dBP) after four weeks of double-blind treatment compared to baseline; and systolic blood pressure (sBP) after four weeks and after eight weeks of double-blind treatment compared to baseline. To evaluate the number and percentage of patients in each treatment group achieving BP control (dBP < 90 mmHg and sBP < 140 mmHg for non-diabetics, and dBP < 80 mmHg and sBP < 130 mmHg for diabetics) after four weeks and after eight weeks of double blind treatment. To evaluate the antihypertensive efficacy, by measuring dBP and sBP, using 24 hour ambulatory blood pressure monitoring (ABPM) (daytime, nighttime and mean 24h ABPM) after eight weeks compared to baseline. To evaluate the risk-benefit ratio of OM/HCTZ 40/25 mg vs. 20/25 mg. To evaluate the safety and tolerability of OM/HCTZ 20/25 mg vs. 40/25 mg combinations after eight weeks of double blind treatment ;Primary end point(s): To compare the efficacy in lowering mean trough sitting dBP between OM/HCTZ 20/25 mg vs. 40/25 mg, in those patients inadequately controlled on OM 40 mg monotherapy, assessed by conventional BP measurements, after eight weeks of double-blind treatment, as compared to baseline (Visit 4, Week 8). | — |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed