Mild to moderate hypertension MedDRA version: 9.1 Level: LLT Classification code 10015488 Term: Essential hypertension
Conditions
Interventions
Trade Name: Amlopin
Pharmaceutical Form: Tablet
INN or Proposed INN: AMLODIPINE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the place
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent has been obtained. 2. A diagnosis of mild to moderate essential hypertension has been made at visit 1 in a non-hospitalised patient. For the diagnosis of mild to moderate hypertension the JNC VI guidelines and the following updates are valid: Subjects presenting a systolic blood pressure of 140 ?179 mmHg inclusive and/or a diastolic blood pressure of 90 ? 109 mmHg inclusive and who are not taking antihypertensive medication. 3. Male or female, aged 18 to 75 years inclusive at the time of the first study visit. 4. Previous treatment for hypertension took place or no anti-hypertensive treatment was in place prior to the study. ''Previously treated'' is defined as having received anti-hypertensive therapy within the last 14 days. ''Previously treated'' subjects must be able to tolerate a maximum 21 day drug free period. 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. A history of uncomplicated myocardial infarction within six months prior to the study is reported. 2. Any history of myocardial infarction (M.I.) complicated by congestive heart failure or post M.I. angina is reported. 3. A primary, haemodynamically cardiac valve disease (e.g. aortic stenosis, aortic insufficiency, mitral insufficiency and mitral stenosis) is diagnosed. 4. Any history of either cerebrovascular accident, including transient ischaemic attack (TIA) and reversible neurological deficit (RIND) or hypertensive encephalopathy is reported. 5. An unstable angina pectoris is diagnosed. 6. Any other clinically relevant cardiovascular disease is reported including: moderate to severe heart failure (NYHA class III or IV) peripheral vascular disease hypertensive retinopathy Keith-Wagener grade III or IV all tachycardias requiring drug treatment 7. Sustained ventricular arrhythmias, atrial fibrillation, bradycardia (<=50 bpm), second degree or complete AV block is reported. 8. A renal insufficiency defined as serum creatinine above 150 μmol/l is diagnosed. 9. Serum liver enzyme concentrations above three times the upper limit of normal are observed. 10. Diabetes mellitus with poor glucose control or complicated by clinically important retinopathy, peripheral neuropathy or autonomic nephropathy is diagnosed. 11. A history of primary aldosteronism, haematological or autoimmune disease is reported. 12.Untreated hyperthyroidism or hyperthyroidism treated with beta-adrenergic blocking drugs is diagnosed/reported. 13. A history of gastro-intestinal surgery which could interfere with the drug absorption is reported. 14. A history of malignancy including leukaemia and lymphoma within the past five years (skin cancer other than melanoma is an exception) is reported. 15. Use of drugs known to affect blood pressure (such as tricyclic anti-depressants, carbenoxolone, phenothiazines, some common cold medications and amphetamines) after the first dose of single-blind placebo medication is reported/detected. 16. A history of drug, medication or alcohol abuse is known. 17. Hypersensitivity or intolerance to either barnidipine or amlodipine or to other calcium antagonists is known. 18. An investigational drug within 28 days prior to the first dose of single-blind medication was taken. 19. Participation in a previous barnidipine study. 20. Any forbidden concomitant medication as listed in appendix 1 of this protocol including ketoconazole and erythromycin, was used. 21. Participation in any clinical trial within 3 months, or participation in more than 3 clinical trials within 12 months, prior to the expected date of enrolment into the study took place. 22. Women of child-bearing potential who are pregnant or intend to become pregnant during the study or who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type plus barrier method, hormonal implants and injectable contraceptives. 23. An allergy to barnidipine, amlodipine or to any other calcium antagonist or any of their components is known. 24. A clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol is observed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of barnidipine and amlodipine on sympathetic activity by assessment of plasma norepinephrine levels in the forearm after 12 weeks of therapy.;Secondary Objective: To investigate tolerability (safety) and anti-hypertensive activity (efficacy) of barnidipine and amlodipine after 12 weeks of therapy. To compare the effect of barnidipine and amlodipine on sympathetic activity by assessing the net norepinephrine balance in the forearm after 12 weeks of therapy in responding* subjects. To compare the effect of barnidipine and amlodipine on forearm norepinephrine spill over after 12 weeks therapy in the first 12 responding subjects. To compare the effect of barnidipine and amlodipine on forearm blood flow and vascular resistance (plethysmography) after 12 weeks of therapy in responding subjects. * SiDBP<90 mmHg and SiSBP<140 mmHg at week 12;Primary end point(s): Forearm plasma norepinephrine levels at baseline and after 12 weeks of therapy as measured after CPT. | — |
Countries
Italy
Outcome results
None listed