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 Hypertensio

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 (?-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 IIIIV),
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.
16. Patients being treated for other diseases with drugs or medication which
may influence BP or interfere with the objectives of the study and which
cannot be withdrawn during the period of the study (e.g. alpha-blockers
for the treatment of benign prostatic hypertrophy or intra-ocular betablockers
for the treatment of glaucoma).
17. Patients being treated at randomisation with any antihypertensive
medication (e.g. calcium channel-blockers, angiotensin II receptor
blocker, diuretics, a- and ß-blocking agents, angiotensin converting
enzyme [ACE] inhibitors, reserpine).
18. Patients with known malabsorption syndromes.
19. Patients who have shown non-compliance with medication and study
procedures during the single-blind placebo run-in ph

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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