Status:
COMPLETED
Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT00353912
Start Date
June 1 2006
End Date
April 1 2007
Last Update
November 18 2016
Active Locations (1)
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1
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936