EFFECTS OF NEBIVOLOL ON THE WALKING ABILITY IN PATIENTS WITH ESSENTIAL HYPERTENSION AND PERIPHERAL ARTERIAL DISEASE INTERMITTENT CLAUDICATIO

Conditions: ESSENTIAL HYPERTENSION AND PERIPHERAL ARTERIAL DISEASE INTERMITTENT CLAUDICATIO

Registration Number: EUCTR2004-004863-32-AT

Lead Sponsor: Berlin-Chemie Menarini

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

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 < 0.90,
•advice on smoking cessation has been given and documented prior to inclusion in the trial; smoking habit is stable for at least 3 months prior to inclusion in the trial.
4.No further improvement in previous exercise training or failure of previous tried exercise training or experience of patient’s lack of compliance regarding exercise training or patients unable to perform exercise training. Walking training must be applied during the trial.
5.Hypertension according to the Joint National Committee on Hypertension (JNC) (systolic blood pressure (SBP) 140-159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg) with or without treatment with antihypertensive drugs

Baseline inclusion criteria
6. ASA 100 mg and/or Clopidogrel 75 mg or Phenprocoumon (Phenprocoumon stable at least three months prior screening visit) and stable background medication for the prevention or therapy of cardiovascular events like ACE inhibitors and/or AT1 inhibitors and/or calcium-channel blockers and/or statins (statins stable for >/= 3 month 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

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 < 3 month stable before Visit 1.
9.Regular use of analgesics with anti-inflammatory potential, i.e. NSAIDs. Treatment on demand and ? 7 days, e.g. for headache is allowed.
10.Treatment with COXII-Inhibitors
11.Anticipated need of newly prescribed treatment with nitrates during the study in patients not pre-treated with those agents at screening stable for ? 3 month
12.Newly diagnosed or unstable angina pectoris (acute coronary syndrome)
13.Concomitant treatment with other beta-blockers (pre treatment can be discontinued until visit 2) or HCT (including combinations) except for the study medication started at visit 3
14.Contraindication to the study drugs:
•Cardiogenic Shock
•heart failure NYHA class III or IV,
•sick-sinus-syndrome including heart blocks (SA node) and/or AV block 2nd and 3rd degree and/or significant arrhythmia and/or bradycardia < 50 bpm,
•Hypotension with systolic blood pressure < 100 mmHg
•bronchial hyperreagibility, bronchial asthma, or history of bronchospasm,
•patients with known SGPT (ALAT) and SGOT (ASAT) levels exceeding three times the upper limit of the investigator's normal range, known serum bilirubin > 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 < 30 ml/min and/or serum creatinine level > 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 except adequately treated basal cell/ squamous cell carcinoma o