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

MENARINI RICERCHE S.P.A.0 sites1,400 target enrollmentSeptember 14, 2007

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 14, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MENARINI RICERCHE S.P.A.

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 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:

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
• 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).