To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01070043
First received: February 6, 2010
Last updated: September 13, 2011
Last verified: September 2011

February 6, 2010
September 13, 2011
June 2009
September 2010   (final data collection date for primary outcome measure)
  • Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline.
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Two arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline.
To compare the blood pressure lowering efficacy with baseline at week 12 by office blood pressure measurement between a single pill combination of 5mg amlodipine and 80 mg valsartan and 160 mg valsartan [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01070043 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean systolic blood pressure (mSBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind phase.
  • Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Validated automated ambulatory blood pressure monitors were dispensed to participants with instructions on correct use. Automated blood pressure readings were obtained every 15-30 minutes during waking hours and every 30-60 minutes during sleep for a total of 24 hours. The change in mean diastolic blood pressure (mDBP) over 24 hours was measured from baseline to 8 weeks of treatment during the double-blind.
  • Number of Participants With Adverse Events During Double-blind Phase [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
To compare tolerability, safety, and other BP lowering efficacy comparison including ambulatory blood pressure measurement (ABPM) parameters at week 12 between a single pill combination of 5mg amlodipine and 80 mg valsartan and 160 mg valsartan. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone
A Single Center, Randomized, Double-blind, Active Controlled, Parallel Group Study to Demonstrate Non-inferiority of a Fixed Dose Combination of 5 mg Amlodipine and 80 mg Valsartan to 160 mg Valsartan in the Treatment of Hypertension

The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypertension
  • High Blood Pressure
  • Drug: Amlodipine 5mg/Valsartan 80 mg
    Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks.
    Other Name: Exforge
  • Drug: Valsartan

    For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks.

    Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) daily with one single tablet size for 8 weeks

    Other Name: Diovan
  • Experimental: Amlodipine 5mg/Valsartan 80 mg
    During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
    Intervention: Drug: Amlodipine 5mg/Valsartan 80 mg
  • Active Comparator: Valsartan 160 mg
    In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
    Intervention: Drug: Valsartan
  • Run-In Valsartan 80 mg
    During run-in period, oral valsartan 80 mg once daily for 4 weeks.
    Intervention: Drug: Valsartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90 mmHg and 120 mmHg.
  • High risk participants ( defined as having: (diabetes mellitus, chronic renal disease, Framingham 10-year risk score >10%, established coronary artery disease (CAD), or CAD equivalents including carotid artery disease, peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA))with hypertension defined as sitting systolic blood pressure between 130 mmHg and 180 mmHg or sitting diastolic blood pressure between 80 mmHg and 120 mmHg.

Exclusion Criteria:

  • Known or suspected secondary hypertension
  • Known New York Heart Association (NYHA) functional class IV Heart Failure
  • History of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
  • Clinically significant valvular disease
  • Women who are pregnant, intend to become pregnant or are breastfeeding
  • Participants who have severe medical condition(s) that in the view of the Investigator prohibits participation in the study
  • Participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.
  • Other protocol-defined inclusion/exclusion criteria may apply
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01070043
CVAA489ATW01
No
Novartis
Novartis
Not Provided
Study Chair: Novartis Novartis Novartis
Novartis
September 2011

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