ESSENTIAL HYPERTENSION AND PERIPHERAL ARTERIAL DISEASE INTERMITTENT CLAUDICATION
Conditions
Interventions
Product Name: Nebilet
Pharmaceutical Form: Tablet
INN or Proposed INN: Nebivolol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: HCT Hexal
Pharmac
Sponsors
Berlin-Chemie Menarini
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Screening inclusion criteria 2. =40 years to 75 years 3.PAD Fontaine’s stage II with: •a history of typical intermittent claudication for at least 6 months with documented lesions by duplex sonography or angiography within the last 36 months prior to inclusion, •actual proven PAD by objective means such as haemodynamics and non-invasive imaging or angiography, •a history (> 1 month before study inclusion) of previous peripheral (lower extremity) vascular intervention such as surgical endarterectomy, by pass grafting or aortic abdominal aneurysm repair or PTA with or without stenting is allowed, •an ankle-brachial pressure index (ABPI) of the worse leg /= 3 months before study inclusion”) 7.Treadmill variability in ACD of = 25% between treadmill test at visit 2 (screening control) and visit 3 (baseline) 8.ACD between 100 m and 300 m at visit 3 (baseline) 9.SBP > 130mmHg and/or DBP > 85 at baseline (Visit 3) 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.PAD with rest pain or leg ulcer or gangrene (Fontaine stage III –IV resp. critical limb ischemia (CLI): systolic ankle pressure = 50 mmHg or systolic toe pressure = 30 mmHg or transcutaneous partial oxygen pressure (tcpO2) = 10 %) 2.Any concomitant disease limiting the exercise capacity of the patient (e.g. but not limited to: angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorder) 3.Standardized exercise training during the study (e.g. supervised physical group-training or individual training) or walking exercises during the study exceeding the all-day habits of the patient as compared to the patient’s habits prior to study inclusion 4.Poorly controlled diabetes mellitus (HbA1c > 8.5%) 5.Orthopedic, neurological or pulmonary concomitant diseases, which limit or may limit the walking distance. 6.Anticipated need for limb, coronary, or carotid vascular surgery or angioplasty during the trial 7.Previous treatment within the last 4 weeks prior to screening or concomitant treatment with rheologic agents (including herbal substances like Ginkgo Biloba (or Padma28) ) or substances that may influence the progression of the PAD or the walking distances except for the trial medication and the background medication 8.Treatment with alpha-blockers or vasodilators as prostaglandin E1, prostaglandin I2 analoga, pentoxiphyllin, naftidrofuryl and buflomedil 1.75 mg/dl (> 30 µmol/l) or clinical evidence of severe hepatic disease or hepatic failure, •untreated phaeocromocytoma, •known metabolic acidosis •known severe renal disease (renal failure with oliguria or unuria, creatinine clearance 150 µmol/l [1.8 mg/100ml]) •known acute glomerulonephritis •known coma and praecoma hepaticum •known articular gout •known hypocaliaemia, hypoatriaemia, hypovolaemia, hypocalcaemia •Fructose incompatibility 15.Acute myocardial infarction and/or stroke during the last 6 months prior to screening 16.Acute pathologic hemorrhage 17.Known Hyperthyroidism 18.Patients with psychiatric diseases 19.Known hypersensitivity to nebivolol or HCT or to any of the ingredients of the study drugs, or any known hypersensitivity to beta-blocker or HCT 20. Prior or active malignancy in the previous 5 years ex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this clinical trial is to evaluate the clinical efficacy (ICD) and tolerability of nebivolol in comparison with hydrochlorothiazide in the treatment of patients with PAD intermittent claudication (Fontaine’s stage II (a+b)) and essential hypertension.;Secondary Objective: -Initial claudication distance (ICD) after 12 weeks treatment -Absolute claudication distance (ACD) after 12 weeks and 24 weeks treatment -ICD and ACD responders after 24 weeks of treatment -Ankle-brachial pressure index (ABPI) after 12 weeks and 24 weeks treatment -Lipid profile after 24 weeks treatment -sCRP (sensitive C-reactive protein) after 24 weeks treatment -Quality of life (QoL) (“Periphere Arterielle Verschlusskranktheit 86 Scale”) after 24 weeks treatment -All-cause mortality -Cardiovascular mortality -Cardiovascular morbidity -Proportion of cardiac catheter examinations, coronary angiography and hospitalizations. ;Primary end point(s): Primary efficacy variable: • Change in the initial claudication distance (ICD) between baseline (visit 3) and end of double-blind treatment (visit 6) as measured by treadmill testing. | — |
Countries
Austria, Germany
Outcome results
None listed