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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00350168
First received: July 7, 2006
Last updated: November 7, 2011
Last verified: November 2011

July 7, 2006
November 7, 2011
June 2006
April 2007   (final data collection date for primary outcome measure)
Change from baseline in MSSBP at week 4
Same as current
Complete list of historical versions of study NCT00350168 on ClinicalTrials.gov Archive Site
  • Change from baseline MSSBP after 2 and 8 weeks of treatment
  • Change from baseline MSDBP after 2, 4 and 8 weeks of treatment
  • Proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 8 weeks of treatment
  • Evaluation of safety and tolerability after 8 weeks of treatment
Same as current
Not Provided
Not Provided
 
Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension
An 8-week Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combination Based Therapy Versus Amlodipine Monotherapy in Patients With Stage II Hypertension

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 stage II hypertensive patients (MSSBP ≥ 160 mmHg).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: valsartan + amlodipine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
647
April 2007
April 2007   (final data collection date for primary outcome measure)

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 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
  • 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.

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00350168
CVAA489A2403
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP