Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy versus Olmesartan Medoxomil 40 mg Monotherapy in Patients with Essential Hypertension - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1400

Inclusion Criteria

1.Male or female Caucasian patients ≥ 18 years of age. A female of childbearing potential may be enrolled providing she:

- has a negative pregnancy test at screening/enrolment and randomisation, and

- is routinely using a highly effective method of birth control resulting in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, e.g. implants, injectables, combined oral contraceptives, hormone containing intra uterine devices (IUDs).

2.Patients with a diagnosis of essential hypertension, either treatment-naive or currently on anti-hypertensive medication in whom it is medically justifiable to withdraw treatment, and who are likely to meet the required BP inclusion criteria at randomisation (see inclusion criteria No. 3 below).

3.BP criteria at randomisation:

a)Mean sitting dBP ≥ 100 mmHg and ≤ 120 mmHg.

b)Mean sitting sBP ≥ 160 mmHg and ≤ 200 mmHg.

4.Patients who have freely given written informed consent.
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

1. Patients with mean sitting sBP values > 200 mmHg and/or dBP > 120 mmHg.

2. Pregnant or nursing women.

3. Patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the tested medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological, oncological, neurological, and psychiatric diseases. The same applies for immunocompromised and/or neutropenic patients.

4. Patients having a history of the following within the last six months: Myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident (stroke), or transient ischaemic attack.

5. Patients with clinically relevant significant abnormal laboratory values at screening/enrolment, including patients with:

aspartate aminotransferase/serum glutamic-oxaloacetic-transaminase (ASAT/SGOT) and alanine aminotransferase/serum glutamic ? pyruvate - transaminase (ALAT/SGPT) greater than twice the upper limit and/or gamma-glutamyltransferase (γ-GT) greater than three times the upper limit of laboratory reference range

and/or

potassium above the upper limit of laboratory reference range (unless high value is due to haemolytic blood sample).

6. Patients with secondary hypertension of any aetiology such as renal disease, pheochromocytoma, or Cushing?s syndrome.

7. Patients with contraindication to Hydrochlorothiazide (HCTZ) and/or OM.

8. Patients with electrocardiographic evidence of 2nd or 3rd degree atrioventricular (AV)-block, atrial fibrillation or other cardiac arrhythmia (requiring treatment), or bradycardia (< 50 beats/min as measured by mean radial heart rate).

9. Patients with severe heart failure (New York Heart Association stage III-IV), a narrowing of the aortic or bicuspid valve, an obstruction of cardiac outflow (obstructive, hypertrophic cardiomyopathy) or symptomatic coronary disease.

10. Patients with clinical evidence of a renal disease (including renovascular occlusive disease, nephrectomy and/or renal transplant, bilateral renal artery stenosis or unilateral renal artery stenosis in a solitary kidney, or severe renal impairment as evidenced by creatinine clearance (CLCR) < 30 mL/min).

11. Patients with uncorrected coarctation of aorta and higher grades of acquired aortic stenosis.

12. Patients with clinically relevant hepatic impairment.

13. Patients with biliary obstruction.

14. Poorly controlled diabetic patients, defined as Type 1 or Type 2 patients with a fasting glucose >12.21 mmol/L [>220 mg/dL].

15. Patients with a history of a wasting disease (e.g. cancer), autoimmune diseases, connective tissue diseases, major allergies, or angioneurotic oedema.

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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