mild to moderate essential hypertension.
Conditions
Interventions
Trade Name: Artedil
Pharmaceutical Form: Capsule*
INN or Proposed INN: MANIDIPINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: Nor
Sponsors
Chiesi Farmaceutici
Eligibility
Sex/Gender
All
Inclusion criteria
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 90? and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 In the Investigator’s opinion the patient should not be withdrawn from their current antihypertensive medication 2.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 | — |
Countries
Germany
Outcome results
None listed