DOUBLE BLIND, PARALLEL GROUP, MULTICENTRE STUDY TO EVALUATE THE EFFICACY AND TOLERABILITY OF CHF 1521 (FIXED COMBINATION OF MANIDIPINE AND DELAPRIL) VS LOSARTAN 50 MG AND HYDROCHLOROTHIAZIDE 12.5 MG IN TYPE 2 DIABETIC HYPERTENSIVE PATIENTS - MORE

Phase 1

• Conditions: ESSENTIAL HYPERTENSIO

• Registration Number: EUCTR2004-001252-36-ES
• Lead Sponsor: Chiesi Farmaceutici SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-07
• Study Completion: 2006-06-16
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

To be included in this study, patients must satisfy the following criteria at the time points specified:
At Visit 1 (Day -7):
? Male or female > 45 years (females of child bearing potential must be using adequate contraceptive precautions)
? Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at enrolment visit
? Patients are attending an out-patient clinic visit
? Type 2 diabetes controlled by diet and oral antidiabetic treatment (HbA1c < 7.5%).
? Patients with mild to moderate uncomplicated essential hypertension with a trough mean sitting DBP ?85 and ?105 mmHg and SBP <160 mmHg
? No evidence of significant cardiovascular disease other than hypertension in the opinion of the investigator
? Written informed consent
? Agreement to attend all study visits as planned in the protocol
? Presence of persistent microalbuminuria (presence of urinary albumin-creatinine ratio: 2.5-25 mg/mmol for men and 3.5-25 mg/mmol for women, confirmed by at least one previous test in the last 3 months) for the patients to be included in the microalbuminuria sub-study.

At Visit 2 (Day 0):
? Mild to moderate hypertension, defined as a trough mean sitting DBP > 85 and < 105 mmHg and SBP <160 mmHg
? 24-hour mean SBP > 130 mmHg (as measured by ABPM)
? For the patients of the Microalbuminuria sub-study, presence of microalbuminuria (urinary albumin-creatinine ratio: 2.5-25 mg/mmol for men and 3.5-25 mg/mmol for women)

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

Patients will be excluded from the study if one or more of the following statements are applicable at enrolment visit:
? In the investigator’s opinion the patient should not be withdrawn from their current antihypertensive medication
? Malignant or secondary hypertension (e.g. patients with hyperaldosteronism, pheochromocytoma, renal artery stenosis, renal parenchymal disease, coarctation of the aorta, Cushing’s disease syndrome)
? History of severe elevated blood pressure (mean sitting DBP >110 mmHg and/or SBP >160 mmHg
? Orthostatic hypotension (difference between mean sitting and standing SBP >20 mmHg)
? Obesity as defined by a Body Mass Index (BMI) > 32 Kg/m2
? Chronic glaucoma treated with beta-blocker eye drops
? Hypertensive retinopathy (Keith Wagener Barker [KWB] scale) grade 3 or 4
? History of hypertensive encephalopathy or cerebrovascular accident
? Presence of cardiac disease other than: uncomplicated hypertensive cardiovascular disease or a single uncomplicated myocardial infarction (MI), which occurred a minimum of twelve months before this study with stable ECG findings for a minimum of twelve months before this study
? History of MI complicated by congestive heart failure or post-MI angina
? Presence of any conduction arrhythmia including bradycardia (heart rate <45 beats per minute (bpm)), tachycardia (heart rate >100 bpm), ventricular arrhythmia
? Presence of significant pulmonary, hepatic, renal, endocrine, metabolic or haematological disease, disorder, or dysfunction
? Laboratory evidence of significant disease including the following:
? serum creatinine >1.5 mg/dl
? serum potassium >10% x upper limit of normal (ULN)
? aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN and/or total serum bilirubin >1.5 x ULN
? Presence of gastrointestinal disease or history of gastrointestinal surgery which would interfere with drug absorption
? History of significant allergies (including multiple drug allergies)
? History of cancer including leukaemia and lymphoma within the past five years (skin cancer, other than melanoma, is an exception)
? Diabetes mellitus requiring treatment with insulin
? Uncontrolled diabetes (HbA1c > 7.5%)
? Chronic use of any drug known to affect blood pressure such as: tricyclic antidepressants, monoamine oxidase inhibitors, neuroleptic drugs (any type), centrally acting antihypertensives (e.g. clonidine, methyldopa, guanfacin, moxonidine), reserpin, non-steroidal anti-inflammatory drug (NSAID) (acetylsalicylic acid [ASA] <0.5 gram/day is allowed), oral or parenteral corticosteroids, antiarrhythmic drugs, digitalis and cardiac glycosides, amphetamine and its derivatives
? Concomitant treatment with other antihypertensive drugs different from the study drugs (i.e. alpha receptor blockers and agonists, beta receptor blockers and agonists, calcium antagonists ACE-inhibitors, angiotensin–II receptor antagonist and diuretics)
? Concomitant use of lithium salts
? Known allergy or a known intolerance to any calcium-antagonist or ACE-inhibitors or ARB or HCTZ.
? Females who are pregnant or lactating
? Use of any investigational drug within 28 days before visit 1
? Patients previously enrolled into the study
? History of drug, medications abuse.

Study & Design

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