EUCTR2006-005556-32-DE
Active, not recruiting
Not Applicable
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
Menarini Ricerche S.p.A.0 sites1,400 target enrollmentApril 30, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Menarini Ricerche S.p.A.
- Enrollment
- 1400
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
- •4\. Patients having a history of the following within the last six months:
- •Myocardial infarction, unstable angina pectoris, percutaneous coronary
Outcomes
Primary Outcomes
Not specified
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