Add-on Study of Olmesartan Medoxomil in Patients with Moderate to Severe Hypertension not Achieving Target Blood Pressure on Amlodipine 5 mg Alone

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 632

Inclusion Criteria

Male and female patients aged 18 years or older.

Patients with moderate to severe hypertension defined as mean sitting sBP not less than (NLT)160 mmHg, mean sitting dBP NLT 100 mmHg and a mean 24-hour dBP, assessed by 24hour-ABPM, of at least 84 mmHg and with at least 30% of daytime dBP readings over 90 mmHg at Visit 2 (i.e. prior to monotherapy treatment) will enter Period I.

Eligible patients who at Screening are already taking a stable dose of AML 5 mg or AML 10 mg for at least four weeks have to fulfil the following criteria before entering directly into Period I:
- previously suffered from moderate to severe hypertension (before first intake of
AML 5 mg or AML 10 mg)
- mean sitting sBP NLT 140 mmHg and mean sitting dBP NLT 90 mmHg at Screening
- a mean 24-hour dBP, assessed by 24hour-ABPM, of at least 80 mmHg and with at
least 30% of daytime dBP readings over 85 mmHg (at Visit 2).

To be randomised, the mean sitting trough dBP must be between 90 and 115 mmHg inclusive and the mean sitting trough systolic blood pressure (sPB) must be NLT 140 mmHg (at Visit 4, conventional BP measurement). Furthermore, the mean 24-hour dBP, assessed by 24hour-ABPM, must be at least 80 mmHg and at least 30% of daytime dBP readings must be over 85 mmHg on monotherapy with amlodipine 5 mg.

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 or lactating.
- Patients with serious disorders which may limit the ability to evaluate the efficacy
or safety of the test drug(s), including cerebrovascular, cardiovascular, renal,
pulmonary, hepatic, gastrointestinal, endocrine/metabolic, haematological/onco-
logical, neurological and psychiatric diseases.
- Patients with poorly controlled diabetes mellitus.
- Patients having a history of the following within the last six months: myocardial
infarction, unstable angina pectoris, percutaneous coronary intervention, heart
failure, cerebrovascular accident, congestive heart failure, or transient ischaemic
attack.
- Patients with clinically significant elevations in laboratory values at Screening.
- Patients with secondary hypertension of any aetiology, such as renal disease,
pheochromocytoma, or Cushing’s syndrome.
- Patients with contraindications to olmesartan medoxomil, amlodipine besilate
and/or hydrochloro-thiazide.

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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