Essential hypertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: Benicar HCT®
Product Name: Combination of Olmesartan Medoxomil and Hydrochlorothiazide
Product Code: OM/HCTZ
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: OLMESARTAN MEDOXO
Sponsors
Menarini Ricerche S.p.A.
Eligibility
Sex/Gender
All
Inclusion 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: 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
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 (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the anti-hypertensive effect of Olmesartan Medoxomil/ Hydrochlorothiazide (OM/HCTZ) 40/12.5 mg combination therapy compared to Olmesartan Medoxomil (OM) 40 mg monotherapy in lowering sitting diastolic blood pressure (dBP) in hypertensive patients after 8 weeks of double-blind treatment (from baseline to the end of the first double-blind treatment phase of the study).;Secondary Objective: 1. Assess anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting systolic blood pressure in hypertensive patients after 8 weeks of double-blind treatment 2. Evaluate percentage of responders in each treatment group after the first 8 weeks of treatment and in up-titrated patients after 16 weeks of treatment. 3. Compare the efficacy in lowering sitting dBP and sBP between patients up-titrated from OM/HCTZ 40/12.5 mg to OM/HCTZ 40/25 mg and patients continuing on OM/HCTZ 40/12.5 mg after 16 weeks of treatment compared to week 8. 4. Compare the efficacy in lowering sitting dBP and sBP between patients up-titrated from OM 40 mg monotherapy to OM/HCTZ 40/12.5 mg and patients continuing on OM 40 mg after 16 weeks of treatment compared to week 8. 5. Evaluate the safety and tolerability of the combinations OM/HCTZ 40/12.5 mg and OM/HCTZ 40/25 mg versus OM 40 mg monotherapy.;Primary end point(s): Change in mean trough sitting dBP between baseline and week 8 or last observation carried forward (LOCF). | — |
Countries
Czech Republic, Denmark, Germany, Italy
Outcome results
None listed