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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00170963
First Posted: September 15, 2005
Last Update Posted: May 17, 2017
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.
Information provided by (Responsible Party):
Novartis
September 10, 2005
September 15, 2005
May 17, 2017
October 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 NCT00170963 on ClinicalTrials.gov Archive Site
  • Change from baseline in mean systolic blood pressure after 8 weeks
  • Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure was 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 Valsartan Alone
Valsartan/Amlodipine 160/5 mg or 160/10 mg Versus Valsartan 160 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Valsartan 160 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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hypertension
Drug: valsartan/amlodipine
Not Provided
Sinkiewicz W, Glazer RD, Kavoliuniene A, Miglinas M, Prak H, Wernsing M, Yen J. Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on valsartan monotherapy. Curr Med Res Opin. 2009 Feb;25(2):315-24. doi: 10.1185/03007990802630588 .

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1018
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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
 
NCT00170963
CVAA489A2305
Not Provided
Not Provided
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Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2017

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