Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertensio

Not Applicable

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

• Registration Number: PER-078-04
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-12-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

• Outpatient patients> 18 years old male or female. Female patients must be in the post-menopausal stage for one year or sterile by surgical methods or must be using an effective method of contraception as a barrier method with spermicide or an intra-uterine device. The use of hormonal contraceptives is not allowed.
• Patients with severe hypertension should have been measured by a standard calibrated aneroid or a mercury sphygmomanometer. Patients should have a MSDBP> 95 mmHg and <120 mmHg at Visit 2 and MSDBO> 110 mmHg and <120 mmHg at Visit 3.

Exclusion Criteria

• Inability to completely discontinue all previous anti-hypertensive medications in a safe manner for a period of 3 weeks required by the protocol
• Knowledge of Keith-Wagener grade III or IV hypertensive retinopathy.
• History of hypertensive encephalopathy or cerebrovascular accident at any time before Visit 1.
• Transient ischemic attack, myocardial infarction, all types of revascularization procedures at any time before Visit 1.
• Heart failure of any kind.
• Second or third degree heart block with or without pacemaker
• Any type of angina.
• Potentially life-threatening coextensive arrhythmia or symptomatic arrhythmia
• Clinically significant cardiac vascular disease.
• Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, stenosis of the unilateral or bilateral renal artery, Cushing´s disease, pheochromocytoma, poikic renal disease.
• Diabetic patients who require treatment with insulin.
• Type 2 diabetics with poor glucose control defined by fasting glycosylated hemoglobin {Hb1Ac)> 7% at Visit 2.
• Administration of any agent indicated for the treatment of hypertension with a minimum of 3 days before Inclusion within the continuous phase of single-blind study (Visit 2), with the permitted exception of that antihypertensive medication that requires to be reduced begun in Visit 1.
• Knowledge or suspicion of contraindications, including history of allergy to angiotensin receptor blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors or thiazide diuretics.
• Any medical or surgical condition that can significantly alter the absorption, distribution, metabolism or excretion of any drug including but not limited to any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, bypass Gastric stapling, gastric stapling or gastric anchoring, isitis 1, current active gastritis, ulcer or gastrointestinal / rectal bleeding, or obstruction of the urinary tract considered as clinically significant for the researcher.
• Any history of pancreatic damage, pancreatitis or evidence of pancreatic insufficiency function / damage within 1 year of the visit 1.
• Evidence of liver disease determined by any of the following tests: SGOT (AST) or SGPT (ALT) values> 2 x ULN at visit 1, a history of hepatic encephalopathy, a history of esophageal varices or a history of portocaval shunt.
• Evidence of renal failure determined by any of the following: serum creatinine> 1.5 mg / dL (men) and> 1.3 mg / dL (women), a history of dialysis, or a history of nephrotic syndrome.
• History of malignancy including leukemia and lymphoma (but not cancer of basal skin cells) within the past 5 years.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The primary assessment for safety and tolerability is the reporting of any serious adverse event (SAE) including death<br>Measure:Safety profiles of the valsartan / amlodipine treatment regimen compared to the lisinopril / hydrochlorothiazide treatment regimen<br>Timepoints:During treatment<br>