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

Berlin-Chemie Menarini0 sites200 target enrollmentDecember 20, 2005

ConditionsESSENTIAL HYPERTENSION AND PERIPHERAL ARTERIAL DISEASE INTERMITTENT CLAUDICATIO

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ESSENTIAL HYPERTENSION AND PERIPHERAL ARTERIAL DISEASE INTERMITTENT CLAUDICATIO
Sponsor: Berlin-Chemie Menarini
Enrollment: 200
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 20, 2005

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Berlin-Chemie Menarini

Eligibility 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 \< 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 European Society of Hypertension Guidelines 2003 (ESH) Grade 1 (mild) and Grade 2 (moderate) (systolic blood pressure (SBP) 140\-179 mmHg and/or diastolic blood pressure (DBP) 90\-109 mmHg) with or without treatment with antihypertensive drugs

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.