Efficacy and Safety of Hydrochlorothiazide Used as Add-on Therapy in Moderately to Severely Hypertensive Patients not Adequately Controlled by Olmesartan Medoxomil 40 mg Monotherapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1500

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

•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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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