EFFICACY AND SAFETY OF ZOFENOPRIL+HYDROCHLOROTHIAZIDE COMBINATION VS. IRBESARTAN+HYDROCHLOROTHIAZIDE COMBINATION IN METABOLIC SYNDROME PATIENTS WITH ESSENTIAL HYPERTENSION NOT CONTROLLED BY PREVIOUS MONOTHERAPY - MEN/09/ZOF-IPE/001

Phase 1

• Conditions: PATIENTS affected by METABOLIC SYNDROME WITH ESSENTIAL HYPERTENSION NOT CONTROLLED BY PREVIOUS MONOTHERAPY; MedDRA version: 9.1 Level: LLT Classification code 10052066

• Registration Number: EUCTR2009-012993-10-IT
• Lead Sponsor: A. MENARINI I.F.R.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-07
• Study Completion: 2012-01-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 482

Inclusion Criteria

Outpatients aged &#8805; 18 years Caucasian males and females Diagnosis of essential hypertension according to Guidelines of European Society of Cardiology. Fasting plasma glucose &#8805; 100mg/dL or on drug treatment for elevated glucose One or more of the following criteria: 1) Waist circumference &#8805;102 cm in men and &#8805;88 cm in women 2) Serum triglycerides &#8805; 150 mg/dL or on drug treatment for elevated triglycerides* 3) HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women or on drug treatment for reduced HDL-C Continuous treatment with the same single antihypertensive drug (single active pharmaceutical ingredient) at least for 4 weeks before inclusion in the study Able and willing to sign informed consent and to comply with study procedures Written informed consent of the patient
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

Serum level of HDL cholesterol < 35 mg/dL and/or Triglycerides > 1000 and/or LDL-C > 190 mg/dL Malignant or secondary hypertension Systolic isolated hypertension Orthostatic hypotension (difference between mean sitting and standing SBP &#8805; 20 mmHg) Heart failure requiring medical treatment Myocardial infarction in the 6 months prior to enrolment cerebrovascular events (including stroke or transient ischemic attack) in the previous 6 months Haemodynamically significant valvulopathy Hereditary/idiopathic angioedema History of angioedema associated with previous ACE-inhibitor therapy Liver pathology (AST or ALT > 3 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than upper limit) Bilateral renal arterial stenosis, or unilateral for patients with a single kidney Renal insufficiency (creatininemia > 200 ?mol/L or 2 mg/dL) Hypokalemia (< 3.5 mEq/L) or hyperkalemia (> 5.0 mEq/L) at least two haematological examinations (if the patient presents at baseline hypo or hyperkalemia, this value has to be confirmed either by a previous examination or by a new one within 3 days) Hyponatremia (< 136 mEq/L); Hypernatremia (Na > 145 mEq/L) Hypercalcemia: (serum Ca) + [(4 serum albumin) x 0,8] > 10,2 mg/dl Hyperuricemia (uric acid > 7 mg/dL) Patients receiving dialysis Hereditary galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorpion Severe concurrent other diseases (cancer, AIDS, liver disease, etc.) Positive history for renal transplantation Dementia, psychosis, alcoholism (> 350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances Introduction of concurrent therapies among those not permitted and which cannot be suspended without harm to the patient Hypersensitivity or contraindications to use of the product under study History of undesired side effects with ACE-inhibitors, AT1-antagonists or diuretics Current treatment with any antihypertensive agents that cannot be safely stopped (investigators decision) by the start of the run-in period Participation in other clinical trials in the previous 4 months Conditions which in the investigators opinion may interfere with the studys execution or due to which the patient should not participate for safety reasons Risk of low patient cooperation Females who are pregnant or lactating Females of childbearing potential not using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified