DOUBLE BLIND, RANDOMISED, PARALLEL GROUP, MULTICENTRE STUDY TO EVALUATE THE EFFECTS OF MANIDIPINE 20 MG VS AMLODIPINE 10 MG AND THE COMBINATION OF MANIDIPINE 10 MG PLUS DELAPRIL 30 MG VS AMLODIPINE 5 MG PLUS DELAPRIL 30 MG ON INTRAGLOMERULAR PRESSURE IN HYPERTENSIVE PATIENTS. - MANTRA

Active, not recruiting

• Conditions: mild to moderate essential hypertension.

• Registration Number: EUCTR2006-006350-10-DE
• Lead Sponsor: Chiesi Farmaceutici

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

To be eligible for study entry all patients must satisfy the following criteria at the time points specified:
Visit 1 (Day -28/-14):
1.Male or female aged >= 18 years <= 65 years (females of child bearing potential must be using adequate contraceptive precautions, i.e. hormonal contraceptives, IUP and sterilisation)
2.Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at enrolment visit
3.Patients with mild to moderate uncomplicated essential hypertension with a trough mean sitting DBP >90? and <110 mmHg and SBP <180 mmHg
4.No evidence of significant cardiovascular disease other than hypertension in the opinion of the Investigator
5.Written informed consent obtained
6.Agreement to attend all study visits as planned in the protocol

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.In the Investigator’s opinion the patient should not be withdrawn from their current antihypertensive medication
2.Malignant or secondary hypertension (e.g. patients with hyperaldosteronism, pheochromocytoma, renal artery stenosis, renal parenchymal disease, coarctation of the aorta, Cushing’s disease syndrome)
3.History of severe elevated blood pressure (mean sitting DBP >110 mmHg and/or SBP >180 mmHg).
4.Obesity as defined by a Body Mass Index (BMI) > 35 kg/m2
5.Hypertensive retinopathy (Keith Wagener Barker [KWB] scale) grade 3 or 4
6.History of hypertensive encephalopathy or cerebrovascular accident
7.Presence of cardiac disease especially aortic stenosis II° and III° 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
8.History of MI complicated by congestive heart failure or post-MI angina
9.Presence of significant pulmonary, hepatic, renal, endocrine, metabolic or haematological disease, disorder or dysfunction
10.Laboratory evidence of significant disease including the following:
11.Serum creatinine >1.5 mg/dl
12.Serum potassium >10% x upper limit of normal (ULN)
13.Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 x ULN and/or total serum bilirubin >2 x ULN
14.Presence of gastrointestinal disease or history of gastrointestinal surgery which would interfere with drug absorption
15.History of significant allergies (including multiple drug allergies)
16.History of cancer including leukaemia and lymphoma within the past five years (skin cancer, other than melanoma, is an exception)
17.Diabetes mellitus requiring treatment with insulin
18.Uncontrolled diabetes (HbA1c > 7.5%)
19.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
20.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)
21.Chronic nitrate treatment, e.g. isosorbide dinitrate or isosorbide mononitrate (short acting nitrates are permitted except just before blood pressure assessments)
22.Concomitiant use of CYP3A4-inhibitors like antiproteinases, cimetidine, ketoconazol, itraconazol, erythromycine, clarithromycine, and concomitant use of CYP3A4-activators like phenytoin, carbamazepine, phenonarbital, rifamicipine.
23.Concomitant use of lithium salts
24.Known allergy or a known intolerance to any calcium-antagonist or ACE-inhibitors or ARB
25.Females who are pregnant or lactating
26.Use of any investigational drug within 28 days before study entry
27.Patients previously enrolled into the study
28.History of drug, medications abuse.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: •To investigate the effects of a once daily oral dose of manidipine 20 mg, compared with once daily amlodipine 10 mg over a 4 week treatment period on intraglomerular pressure in patients with mild to moderate essential hypertension. ;Secondary Objective: •To investigate the effects of a once daily oral dose of a combination of manidipine 10 mg plus delapril 30 mg, compared with once daily amlodipine 5 mg plus delapril 30 mg over a 4 week treatment period on intraglomerular pressure <br><br>It is not possible to note our further secondary objectives due to the maximum lenght limit of the software. However, all secondary objectives are listed in the study protocol.;Primary end point(s): intraglomerular pressure