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STUDY WITH AMBULATORY MONITORING OF BLOOD PRESSURE AND EVALUATION OF THE EFFECT OF THE SUSPENSION OF DRUGS IN THE STATE OF EQUILIBRIUM

A DOUBLE BLIND COMPARISON OF THE EFFECTS OF AMLODIPINE AND ENALAPRIL ON INSULIN SENSITIVITY IN HYPERTENSIVE PATIENTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-004-99
Enrollment
Unknown
Registered
1999-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Grupo 2(Nombre Provisional) Type of group
This study will consist of 3 phases: Phase I: Placebo (Weeks -2 to 0)
Phase II: Active Treatment (Weeks O to 8), in which amlodipine will be compared (once per day) vs. enalapril (once a day) in my double blind design, double mannequin. Patients who are not in the Desir
and Phase III: in which patients will receive a dose of placebo that simulates a missed dose. Patients who are receiving antihypertensive treatment and who are suitable. these studies should s

Sponsors

PFIZER S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) The patient has consented to participate in accordance with the relevant provisions of the Helsinki Declaration (Appendix B). b) Patients of both sexes> 18 and 90 and 85 mmHg.

Exclusion criteria

Exclusion criteria: a) Pregnant or lactating women and those with pregnancy potential. b) Concomitant treatment with other antihypertensive drugs or other drugs that could alter blood pressure, or oral anticoagulants. Patients who are under previous antihypertensive treatment should only be included in the study if the Investigator considers that the suspension of previous antihypertensive therapy would not be dangerous. c) Intermittent or unstable hypertension; Systolic BP (SBP)> 200 mmHg or DBP> 115 mmHg in two consecutive weekly visits. d) Malignant or accelerated hypertension (Retinopathy Grade IV) e) History of secondary hypertension, such as (1) Hyperaldosteronism; (2) Pheochromocytoma; (3) Renal artery stenosis; (4) Aortic coarctation; (5) Cushing´s disease or syndrome; (6) Drugs as oral contraceptives. f) Hematological, hepatic or major cardiac disease; myocardial infarction or cerebrovascular accident in the 6 months prior to study entry; ischemic heart disease that requires the use of anti-ischemic drugs (beta-blockers, calcium blockers or nitrates); concurrent or previous evidence of heart failure; clinically significant abnormalities of cardiac conduction, Wolf Parkinson White Syndrome, second and third degree AV block; serum creatinine> 1.5 mg / dl; presence of clinically significant abnormalities in laboratory tests of liver function (TOO, TGP) that exceed 2 times the normal higher value. g) Patients presenting with angina pectoris with Functional Class NYHA> II. h) Greater metabolic or endocrine disease. i) History of chronic diarrhea, peptic ulcer, gastrectomy, or any other intestinal condition that may affect the absorption of the study drug. j) History of asthma, eczema, proven allergy or intolerance to inhibitory drugs of the EGA or calcium blockers. k) Terminal illness or other condition that prevents the completion and evaluation of the therapy of the drugs under study. 1) History of alcohol or drug abuse, psychosis, antagonistic personality, low motivation or any other emotional or intellectual problem that could invalidate the written consent, or limit the patient´s ability to comply with the requirements of the protocol. m) Participation in any other study that involves research or sale products concomitantly or within the month prior to entering the study.

Outcome results

None listed

Source: REPEC (via WHO ICTRP)