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Completed

NCT Number: NCT00413413

Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Valsartan/amlodipine 80/5 mg

Drug

1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily

Valsartan 80 mg

Drug

1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Valsartan 160 mg

Drug

1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Primary outcomes

  1. Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

    Time frame: Baseline to end of study (Week 8)

    Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.

Secondary outcomes

  1. Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)

    Time frame: Baseline to end of study (Week 8)

    Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.

  2. Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)

    Time frame: Baseline to end of study (Week 8)

    A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.

  3. Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)

    Time frame: End of study (Week 8)

    Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.

  4. Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)

    Time frame: End of study (Week 8)

    Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controled, Parallel Study, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Valsartan 80 mg and Valsartan 160 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80 mg Monotherapy.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Dec 19, 2006
Registry last updated
Apr 28, 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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