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Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension
This study has been completed.
Study NCT00413049   Information provided by Novartis
First Received: December 18, 2006   Last Updated: October 27, 2008   History of Changes

December 18, 2006
October 27, 2008
January 2007
November 2007   (final data collection date for primary outcome measure)
Diastolic blood pressure changes at baseline versus endpoint (Wk 8) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Diastolic blood pressure changes at baseline versus endpoint (Wk 8)
Complete list of historical versions of study NCT00413049 on ClinicalTrials.gov Archive Site
  • Systolic blood pressure changes from baseline compared to endpoint (Wk 8) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Diastolic and systolic blood pressure changes from baseline to various time points [ Time Frame: baseline to various time points ] [ Designated as safety issue: No ]
  • Diastolic and systolic blood pressure response and control rates [ Time Frame: during treatment period ] [ Designated as safety issue: No ]
  • Safety and tolerability of valsartan 80 mg plus amlodipine 5 mg and amlodipine 5 mg alone. [ Time Frame: during treatment period ] [ Designated as safety issue: No ]
  • Systolic blood pressure changes from baseline compared to endpoint (Wk 8)
  • Diastolic and systolic blood pressure changes from baseline to various time points
  • Diastolic and systolic blood pressure response and control rates
  • Safety and tolerability of valsartan 80 mg plus amlodipine 5 mg and amlodipine 5 mg alone.
 
Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension
A Multi-Center, Double Dummy, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5mg to Amlodipine 5mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5mg Monotherapy.

This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Hypertension
  • Drug: Valsartan plus amlodipine
  • Drug: Amlodipine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
698
 
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female outpatients >= 18 years and < 86 years
  • Patients with essential diastolic hypertension
  • At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and < 10 mmHg
  • patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmHg
  • At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg and < 100 mmHg
  • At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg and < 110 mmHg

Exclusion Criteria:

  • Severe hypertension >= 180/110 mmHg
  • Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
  • Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2
  • History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
  • Malignant hypertension
  • All patients with Type I diabetes and those patients with Type 2 diabetes who are not well controlled based on the investigator's clinical judgment
  • Pregnant or nursing women
  • History of heart failure
  • Angina pectoris
  • Second or third degree heart block
  • Life threatening or symptomatic arrhythmias
  • Clinically significant valvular heart disease
  • Evidence of a secondary form of hypertension
  • Known or moderate malignant retinopathy
  • Evidence of hepatic disease
  • Evidence of renal impairment Other protocol-defined exclusion criteria may apply.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00413049
Novartis Medical Director, Novartis Pharmaceuticals
CVAA489A2315
Novartis
 
Study Director: Novartis Pharmaceuticals Sponsor GmbH
Novartis
October 2008

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