Overview

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

Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
All
Summary
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 Black stage II hypertensive patients (MSSBP ≥ 160 mmHg).
Phase:
Phase 3
Details
Lead Sponsor:
Novartis
Treatments:
Amlodipine
Valsartan
Criteria
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 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.

- 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

Other protocol-defined inclusion/exclusion criteria may apply