[French multicenter study of Triatec (ramipril) in ambulatory patients: methodology and trial structure].
Triatec is a new ACE inhibitor. The initial recommended dose is a single daily intake of 2.5 to 10 mg. In order to validate a dose escalation schedule allowing each patient to be treated with the minimal effective dose, a multicenter clinical trial has been conducted by 102 general practitioners, under conditions close to their habits, on 770 mild hypertension patients with a 16 weeks follow-up. The trial consisted in 4 periods: after a placebo run-in period, the patients whose hypertension remained (supine diastolic blood pressure -DBP-between 95 and 115 mmHg) would receive 2.5 mg of Triatec a day, for 3 weeks. After completion of this first treatment period, non-responders (DBP greater than 90 mmHg) to Triatec 2.5 mg would receive 5 mg of Triatec a day, during 3 weeks. Non responders to Triatec 5 mg a day would then be randomized into a 6 weeks double-blind parallel group trial comparing monotherapy by 10 mg of Triatec to the association of Triatec 5 mg with Lasilix 20 mg. In France, Good Clinical Practice (GCP) is a set of recommendations aiming to ensure a high quality standard for clinical trials. To put these recommendations into practice within the context of a large study of Triatec, national and local structures were implemented for a computer-assisted follow-up. Real-time data control for the 770 patients enrolled in this trial made a first presentation of the results to the Scientific Committee possible a mere 10 weeks after the last visit of the last patient was recorded. It also ensured the most reliable data to be processed.(ABSTRACT TRUNCATED AT 250 WORDS)
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Département Développement, Laboratoires Hoechst, Paris-La Défense.
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D000328:Adult; D000368:Aged; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D001643:Bridged Bicyclo Compounds / Q000627:therapeutic use*; D001952:Bridged-Ring Compounds / Q000627:therapeutic use*; D005602:France; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007256:Information Systems; D008875:Middle Aged; D008905:Minicomputers; D015337:Multicenter Studies as Topic; D017257:Ramipril
D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D001643:Bridged Bicyclo Compounds; D001952:Bridged-Ring Compounds; D017257:Ramipril
L'étude multicentrique française ambulatoire du Triatec (ramipril): méthodologie et structure de l'essai.