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

Not Applicable

• Conditions: -I10 Essential (primary) hypertension; Essential (primary) hypertension; I10

• Registration Number: PER-004-99
• Lead Sponsor: PFIZER S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-08-24
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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 <80 years with a recent diagnosis or history of essential hypertension.
c) Outpatients diagnosed with mild and moderate hypertension defined as:
1) an average of the diastolic blood pressure (DBP) measurements> 90 and <110 mmHg (without antihypertensive medication) in the sitting position. The mean blood pressure will be documented twice with a minimum difference of 1 week and without antihypertensive medication (the difference between the averages should not be more than 10 mmHg). 1. Diuretic agents should be discontinued at least 1 week before the Placebo Phase; and 2) baseline daytime mean of ambulatory PAD> 85 mmHg.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified