Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension
This study has been completed.
Information provided by (Responsible Party):
First received: July 17, 2006
Last updated: November 7, 2011
Last verified: November 2011
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).
Drug: valsartan + amlodipine
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A 12-week, Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combo Based Therapy vs Amlodipine Monotherapy in Black Patients With Stage II Hypertension
Primary Outcome Measures:
- Change from baseline in MSSBP at week 8
Secondary Outcome Measures:
- 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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
- 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.
- 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
- Significant valvular heart disease
- Active gout
Other protocol-defined inclusion/exclusion criteria may apply
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00353912
|E. Hanover, New Jersey, United States, 07936 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 17, 2006
||November 7, 2011
||United States: Food and Drug Administration
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 19, 2014
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists