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

Last updated: April 26, 2011
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Stress

Vascular Diseases

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT00413413
CVAA489A2316
  • Ages 18-85
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 sittingdiastolic blood pressure < 100 mmHg

  • At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHgand < 100 mmHg

  • At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHgand < 110 mmHg

Exclusion

Exclusion Criteria:

  • Severe hypertension >= 180/110 mmHg

  • Known or suspected contraindications, including a history of allergy orhypersensitivity to valsartan or amlodipine or to other drugs with similar chemicalstructures

  • Inability to discontinue all prior antihypertensive medications safely for a maximumperiod of up to 28 days prior to Visit 2

  • History of hypertensive encephalopathy, cerebrovascular accident or transient ischemicattack, myocardial infarction or other types of revascularization

  • Malignant hypertension

  • All patients with Type I diabetes and those patients with Type 2 diabetes who are notwell 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.

Study Design

Total Participants: 1134
Study Start date:
January 01, 2007
Estimated Completion Date:
November 30, 2007

Connect with a study center

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

    Beijing, 100020
    China

    Site Not Available

  • Beijing General Hospital of Beijing Military Region

    Beijing, 100700
    China

    Site Not Available

  • Beijing Hospital

    Beijing, 100730
    China

    Site Not Available

  • The First Affiliated Hospital of Medical College of Zhejiang University

    Hangzhou, 310007
    China

    Site Not Available

  • The First People's Hospital of Hangzhou

    Hangzhou, 310006
    China

    Site Not Available

  • The Second Affiliated Hospital of Medical College of Zhejiang University

    Hangzhou, 310006
    China

    Site Not Available

  • Southeast University Affiliated Zhong Da Hospital

    Nanjing, 210009
    China

    Site Not Available

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, 210029
    China

    Site Not Available

  • Department of cardiology, Ruijin hospital

    Shanghai, 200025
    China

    Site Not Available

  • Department of cardiology, Ruijin hospital;

    Shanghai, 200025
    China

    Site Not Available

  • Fudan University affiliated zhongshan hospital

    Shanghai, 200032
    China

    Site Not Available

  • Second Military Medical University Affiliated Changhai Hospital

    Shanghai, 200433
    China

    Site Not Available

  • Second Military Medical University Affiliated Changzheng Hospital

    Shanghai, 200003
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang, 110001
    China

    Site Not Available

  • The people's Hospital of Liaoning Province

    Shenyang, 110016
    China

    Site Not Available

  • Second Hospital of Hebei University of Medical Sciences

    Shijiazhuang, 050050
    China

    Site Not Available

  • The People's Hospital of Hebei Provincial

    Shijiazhuang, 050051
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006
    China

    Site Not Available

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004
    China

    Site Not Available

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