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

• ClinicalTrials.gov Identifier: NCT01070043
• Recruitment Status: Completed
• First Posted: February 17, 2010
• Results First Posted: October 19, 2011
• Last Update Posted: October 19, 2011
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Tracking Information

• First Submitted Date: February 6, 2010
• First Posted Date: February 17, 2010
• Results First Submitted Date: September 13, 2011
• Results First Posted Date: October 19, 2011
• Last Update Posted Date: October 19, 2011
• Study Start Date: June 2009
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2011)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement [ Time Frame: Baseline and 8 weeks ]
  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 ]
  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.

• Original Primary Outcome Measures (submitted: February 16, 2010): 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 ]

Current Secondary Outcome Measures (submitted: September 13, 2011)

• Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours [ Time Frame: Baseline and 8 weeks ]
  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 ]
  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 ]

• Original Secondary Outcome Measures (submitted: February 16, 2010): 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 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone
• Official Title: 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hypertension
• High Blood Pressure

Intervention

• 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

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 13, 2011): 60
• Original Estimated Enrollment (submitted: February 16, 2010): 40
• Actual Study Completion Date: September 2010
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT01070043
• Other Study ID Numbers: CVAA489ATW01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novartis
• Original Responsible Party: Novartis Pharmaceuticals, Sponsor
• Current Study Sponsor: Novartis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Novartis Novartis; Novartis

• PRS Account: Novartis
• Verification Date: September 2011