Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension

Novartis

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: valsartan + amlodipine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00350168

CVAA489A2403

Details and patient eligibility

About

The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).

Enrollment

647 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older.
Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.

Exclusion criteria

History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
Inability to stop all prior blood pressure medications safely
Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
Controlled blood pressure (systolic BP < 140 mmHg) taking more than 3 antihypertensive medications at screening
Systolic BP ≥ 140 mmHg and < 180 mmHg taking more than two antihypertensive medications at screening
Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening
History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina
Type 1 diabetes
Poorly controlled Type 2 diabetes
History of heart failure
Arrhythmia
Significant valvular heart disease
Active gout
History of autoimmune diseases
History of multiple drug allergies
Liver disease
Pancreatic injury within 1 year of screening
Evidence of kidney impairment or history of dialysis
Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.
Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed
Pregnant or nursing (lactating) women
History of malignancy of any organ system within the past five years
Any severe, life-threatening disease within the past five years
History of drug or alcohol abuse within the last 2 years.