Primary arterial hypertension MedDRA version: 17.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Norvasc 10 mg tablets
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Amlodipine
Other descriptive name: AMLODIPINE BESILATE
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Krka, d.d. Novo mesto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Mean SeDBP of 90 to 109 mm Hg at the screening ( Visit 1/screening) and the baseline (Visit 2) • Men and women, aged 18-75 years • Written informed consent 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 560 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: • History of hypersensitivity to any components of the medicines used in the trial or history of intolerance to amlodipine and/or olmesartan medoxomil • Known secondary arterial hypertension (e.g. pheochromocytoma, primary aldosteronism, renal artery stenosis) • History of left ventricular hypertrophy or obstruction of the left ventricular outflow tract (e.g. hemodynamically significant aortic stenosis) • Ischaemic heart disease or ischaemic cerebrovascular disease • Heart failure on medication therapy • Chronic disease other than arterial hypertension requiring chronic use of beta-blockers or calcium antagonists (e.g. tachyarrhythmia, glaucoma) • Clinically and laboratory evident biliary obstruction with both jaundice and increased total serum bilirubin over 50 micromol / l • Renal impairment (creatinine clearance < 60 mL/min) • Previous or current therapy with olmesartan medoxomil and amlodipine taken concomitantly • Current therapy with: • Other antihypertensive drugs, if introduced/modified less than 6 weeks prior to enrolment • Any “not allowed” medication(s) listed in section 6.2. • Any acute disease (severe infection, exacerbation or uncontrolled phase of a chronic disease, major trauma, surgery) within 30 days prior to screening visit • Following clinically relevant laboratory or ECG findings: • i.e. significant anaemia with hemoglobin less than 80 g/l, • significant thrombocytopenia with platelet count less than 50.000/microliter • serum AST and/or ALT and/or ALP of more than 3 x ULN (upper limit of normal) • hyperkalaemia (serum potassium of more than 5 mmol/l) • A-V block grade 2 or 3 • ECG signs of acute ischemia • Symptomatic bradycardia with heart rate less than 50/min • Smoking more than 20 cigarettes/day • Pathological clinical states that could affect subject’s compliance, or have any impact on subject’s short-term survival rate (malignant diseases, excessive alcohol consumption, drug abuse or drug addiction, psychiatric conditions) • Pregnancy and lactation • Women who are planning to become pregnant before the end of involvement in the trial • Women of childbearing potential with no reliable contraception • Subjects currently participating in another clinical trial • Subject’s refusal to participate with the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to compare the treatment effect of fixed-dose combinations of olmesartan medoxomil/amlodipine (TIMP) to those of the component monotherapies (RIMPs) and placebo in subjects with grade 1 or grade 2 arterial hypertension. Within the primary objective the superiority of the treatment effect of TIMPs over each RIMP of respective strength and placebo is expected to be demonstrated.;Secondary Objective: Secondary objective is to assess the safety profile of TIMPs in comparison with each RIMP and placebo and to demonstrate similar safety profile in TIMPs and RIMPs in subjects with grade 1 or grade 2 arterial hypertension.;Primary end point(s): The primary efficacy endpoint is defined as the mean change from baseline in seated diastolic pressure at end-therapy visit on week 8.;Timepoint(s) of evaluation of this end point: Baseline timepoint: day 1 of the Period 2 (active treatment period) End-therapy timepoint: day 57 from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints: o Mean change from baseline in SeSBP at week 8 o Mean change from baseline in SeSBP at week 2 o Mean change from baseline in SeSBP at week 4 o Mean change from baseline in SeDBP at week 2 o Mean change from baseline in SeDBP at week 4 o Proportion of subjects with SeSBP reduction from baseline = 20 mm Hg at week 8 o Proportion of subjects with SeDBP reduction from baseline = 10 mm Hg at week 8 o Proportion of subjects reaching BP goal of less than 140/90 mm Hg at week 2 o Proportion of subjects reaching BP goal of less than 140/90 mm Hg at week 4 o Proportion of subjects reaching BP goal of less than 140/90 mm Hg at week 8 o Mean changes from baseline in average 24-hour SBP at week 8 in a subgroup of subjects with 24-hour ABPM o Mean changes from baseline in average 24-hour DBP at week 8 in a subgroup of subjects with 24-hour ABPM Safety endpoints: - Overall incidence of adverse reactions (drug-related adverse events) - Incidence of adverse reactions stratified by specific type of adverse reaction - A number/percentage of subjects unable to finish both active treatment periods due to clinically significant adverse reaction - Mean change from baseline in selected laboratory parameters at week 8;Timepoint(s) of evaluation of this end point: - Baseline timepoint: day 1 of the Period II (active treatment period) fot all the secondary endpoints - 2-week active treatment timepoint: day 15 with respect to baseline timepoint - 4-week active treatment timepoint: day 29 with respect to baseline timepoint - End therapy timepoint: day 57 with respect to baseline timepoint The timepoint for secondary efficacy endpoints is stated in the endpoint name. The final timepoint for all safety endpoints is End therapy timepoint. | — |
Countries
Germany, Hungary, Poland, Romania
Contacts
Public ContactInfopointKKKL172014
krka, d.d. Novo mesto
Outcome results
None listed