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Completed

NCT Number: NCT01070043

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases High Blood Pressure Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taipei, 11217, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amlodipine 5mg/Valsartan 80 mg

Drug

Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks.

Other names: Exforge

valsartan

Drug

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 names: Diovan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Number of Participants With Adverse Events During Double-blind Phase

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 17, 2010
Registry last updated
Oct 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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