Hypertension
Conditions
Keywords
Blood, Venous, Systolic, Diastolic, Pulse, Pressure
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 patients (MSSBP ≥ 160 mmHg).
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in MSSBP at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| change from baseline MSSBP after 2, 4 and 12 weeks of treatment | — |
| change from baseline MSDBP after 2, 4, 8 and 12 weeks of treatment | — |
| proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 12 weeks of treatment | — |
| evaluation of safety and tolerability after 12 weeks of treatment | — |
Countries
United States
Outcome results
None listed