We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00171002
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 17, 2017
Information provided by (Responsible Party):

Brief Summary:
This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan/amlodipine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 936 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of Valsartan/Amlodipine 160/10 mg Versus Amlodipine 10 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Amlodipine 10 mg Monotherapy
Study Start Date : November 2004
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures :
  1. Change from baseline in systolic blood pressure after 8 weeks
  2. Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
  3. Diastolic blood pressure less than 90 mmHg after 8 weeks

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Patients with uncomplicated, essential hypertension

Exclusion Criteria:

  • Severe hypertension
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Insulin dependent diabetes
  • Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171002

Investigative Centers, Germany
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171002     History of Changes
Other Study ID Numbers: CVAA489A2306
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Novartis:
Hypertension, high blood pressure, valsartan, amlodipine

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