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 sBP of = 160 and dBP =100 mmHg, at Screening in patients not currently on antihypertensive medication (newly diagnosed patients). •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 and 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 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, 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 dBP between OM/HCTZ 40/12.5 mg and 40/25 mg versus OM 40 mg monotherapy, and between OM/HCTZ 40/12.5 mg versus 20/12.5 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).;Secondary Objective: •To evaluate the additional antihypertensive efficacy of combinations of OM with HCTZ 40/25 mg & 40/12.5 mg compared to OM 40 mg and between OM/HCTZ 40/12.5 mg vs. 20/12.5 mg in lowering mean trough sitting dBP and sBP, after 4wks of double blind treatment and after 4wks & 8wks of double blind treatment, respectively, compared to baseline •To evaluate the antihypertensive efficacy by measuring dBP & sBP using 24hr ABPM after 8wks of double blind treatment compared to baseline •To evaluate the number and % of patients in each treatment group achieving target BP (dBP < 90 mmHg and sBP < 140 mmHg for non-diabetics and dBP < 80 mmHg and sBP < 130 mmHg for diabetics) after 4 & 8wks of double blind treatment •To evaluate the risk-benefit ratio of the OM/HCTZ 40/12.5 mg vs. 20/12.5 mg combination •To evaluate the safety and tolerability of combinations of OM/HCTZ 40/25 mg, 40/12.5 mg vs. OM 40 mg monotherapy, and OM/HCTZ 40/12.5 mg vs. 20/12.5 mg, after 8wks of double-blind treatment;Primary end point(s): The primary endpoint is the mean change from baseline (Visit 4, Week 8) to the end of the eight-week double-blind treatment (Visit 6, Week 16) in mean trough sitting dBP, assessed by conventional BP measurement. | — |
Countries
Czech Republic, France, Germany, Spain
Outcome results
None listed