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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00353912
First received: July 17, 2006
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Hypertension
 Drug: valsartan + amlodipine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

Enrollment: 571
Study Start Date: June 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353912

Locations
United States, New Jersey
Novartis Pharmaceuticals
E. Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00353912     History of Changes
Other Study ID Numbers: CVAA489A2402
Study First Received: July 17, 2006
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Blood
Venous
Systolic
 Diastolic
Pulse
Pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013