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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: July 7, 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 stage II hypertensive patients (MSSBP ≥ 160 mmHg).

Condition Intervention Phase
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: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in MSSBP at week 4

Secondary Outcome Measures:
  • 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

Enrollment: 647
Study Start Date: June 2006
Study Completion Date: April 2007
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:   Both

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350168

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

Additional Information:
No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00350168     History of Changes
Other Study ID Numbers: CVAA489A2403
Study First Received: July 7, 2006
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Blood pressure
Venous pressure
Systolic pressure
Diastolic pressure
Pulse pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
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 April 22, 2014