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
  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 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: 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)
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Novartis Pharmaceuticals Corp
E. Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 18, 2014