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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171002
First received: September 10, 2005
Last updated: November 7, 2011
Last verified: June 2006

September 10, 2005
November 7, 2011
November 2004
June 2005   (final data collection date for primary outcome measure)
Change from baseline in diastolic blood pressure after 8 weeks
Not Provided
Complete list of historical versions of study NCT00171002 on ClinicalTrials.gov Archive Site
  • Change from baseline in systolic blood pressure after 8 weeks
  • Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
  • Diastolic blood pressure less than 90 mmHg after 8 weeks
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Not Provided
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Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Amlodipine Alone
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

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

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
Schunkert H, Glazer RD, Wernsing M, Yen J, Macarie CE, Vintila MM, Romanova J. Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on amlodipine monotherapy. Curr Med Res Opin. 2009 Nov;25(11):2655-62.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
936
June 2005
June 2005   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00171002
CVAA489A2306
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2006

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