Biomaterial Database

Comparison of response rates to the angiotensin-converting enzyme inhibitor ramipril in mild-to-moderate hypertension in a double-blind, parallel-group study and an open single-blind study. 1991

D Vasmant, and P Lendresse, and J C Lemarie, and M Gallet

Laboratoires Hoechst, Paris La Défense, France.

Appropriate clinical trial methodologies in general practice and suitable end points for dose-finding studies are discussed with reference to antihypertensive drugs in general and angiotensin-converting enzyme (ACE) inhibitors in particular. Two clinical studies were conducted with ramipril, a new nonsulfhydryl ACE inhibitor, to identify the minimum effective dose for the management of mild-to-moderate hypertension. Study 1 was a double-blind, parallel-group, randomized design with three treatment groups (placebo and 2.5 and 5 mg of ramipril), and study 2 was an open, single-blind design with individual dose titration from 2.5 to 5 mg of ramipril if the diastolic blood pressure (DBP) was greater than 90 mm Hg after 3 weeks. Response rates and DBP reductions with 2.5 mg of ramipril were similar in both studies, although overall response rates, DBP reductions, and side effect incidence appeared to be greater in the open, single-blind, dose-titration study. It is concluded that study methodology apparently influences efficacy and tolerability.

UI	MeSH Term	Description	Entries
D006973	Hypertension	Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.	Blood Pressure, High,Blood Pressures, High,High Blood Pressure,High Blood Pressures
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000806	Angiotensin-Converting Enzyme Inhibitors	A class of drugs whose main indications are the treatment of hypertension and heart failure. They exert their hemodynamic effect mainly by inhibiting the renin-angiotensin system. They also modulate sympathetic nervous system activity and increase prostaglandin synthesis. They cause mainly vasodilation and mild natriuresis without affecting heart rate and contractility.	ACE Inhibitor,ACE Inhibitors,Angiotensin Converting Enzyme Inhibitor,Angiotensin I-Converting Enzyme Inhibitor,Angiotensin-Converting Enzyme Inhibitor,Kininase II Inhibitor,Kininase II Inhibitors,Angiotensin I-Converting Enzyme Inhibitors,Angiotensin-Converting Enzyme Antagonists,Antagonists, Angiotensin-Converting Enzyme,Antagonists, Kininase II,Inhibitors, ACE,Inhibitors, Angiotensin-Converting Enzyme,Inhibitors, Kininase II,Kininase II Antagonists,Angiotensin Converting Enzyme Antagonists,Angiotensin Converting Enzyme Inhibitors,Angiotensin I Converting Enzyme Inhibitor,Angiotensin I Converting Enzyme Inhibitors,Antagonists, Angiotensin Converting Enzyme,Enzyme Antagonists, Angiotensin-Converting,Enzyme Inhibitor, Angiotensin-Converting,Enzyme Inhibitors, Angiotensin-Converting,II Inhibitor, Kininase,Inhibitor, ACE,Inhibitor, Angiotensin-Converting Enzyme,Inhibitor, Kininase II,Inhibitors, Angiotensin Converting Enzyme
D000959	Antihypertensive Agents	Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS.	Anti-Hypertensive,Anti-Hypertensive Agent,Anti-Hypertensive Drug,Antihypertensive,Antihypertensive Agent,Antihypertensive Drug,Anti-Hypertensive Agents,Anti-Hypertensive Drugs,Anti-Hypertensives,Antihypertensive Drugs,Antihypertensives,Agent, Anti-Hypertensive,Agent, Antihypertensive,Agents, Anti-Hypertensive,Agents, Antihypertensive,Anti Hypertensive,Anti Hypertensive Agent,Anti Hypertensive Agents,Anti Hypertensive Drug,Anti Hypertensive Drugs,Anti Hypertensives,Drug, Anti-Hypertensive,Drug, Antihypertensive,Drugs, Anti-Hypertensive,Drugs, Antihypertensive
D001643	Bridged Bicyclo Compounds	Saturated alicyclic hydrocarbon molecules consisting of two rings that have two non-adjacent atoms in common.	Bicyclo Compounds,Bicyclo Compounds, Bridged
D016037	Single-Blind Method	A method in which either the observer(s) or the subject(s) is kept ignorant of the group to which the subjects are assigned.	Single-Masked Study,Single-Blind Study,Single-Masked Method,Method, Single-Blind,Method, Single-Masked,Methods, Single-Blind,Methods, Single-Masked,Single Blind Method,Single Blind Study,Single Masked Method,Single Masked Study,Single-Blind Methods,Single-Blind Studies,Single-Masked Methods,Single-Masked Studies,Studies, Single-Blind,Studies, Single-Masked,Study, Single-Blind,Study, Single-Masked
D017257	Ramipril	A long-acting angiotensin-converting enzyme inhibitor. It is a prodrug that is transformed in the liver to its active metabolite ramiprilat.	Acovil,Altace,Carasel,Delix,HOE-498,Ramace,Triatec,Tritace,Vesdil,Zabien,HOE 498,HOE498