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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
High Blood Pressure
 Drug: Amlodipine 5mg/Valsartan 80 mg
Drug: Valsartan
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
Active Comparator: Valsartan 160 mg
In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
 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
Run-In Valsartan 80 mg
During run-in period, oral valsartan 80 mg once daily for 4 weeks.
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070043

Locations
Taiwan
Taipei, Taiwan, 11217
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01070043     History of Changes
Other Study ID Numbers: CVAA489ATW01
Study First Received: February 6, 2010
Results First Received: September 13, 2011
Last Updated: September 13, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Novartis:
Hypertension
valsartan
amlodipine
high blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Amlodipine, valsartan drug combination
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2013