Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.

Overview

To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.

Full Title of Study: “A 8-week, Multi Center(10),Single Arm, Open-labeled Prospective Study of Valsartan 160 mg in 200 Mild to Moderate Chinese Hypertension Patients Forced Titrated From 2-week Therapy of Valsartan 80 mg.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2013

Interventions

  • Drug: Valsartan
    • 80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks

Arms, Groups and Cohorts

  • Experimental: valsartan
    • After 1-week screening period, all of the eligible patients receive valsartan 80mg/day for 2 weeks, then the dosage will be titrated to 160mg/day for further 8 weeks therapy for all of the subjects.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline and week 2 in blood pressure at week 10
    • Time Frame: Baseline, 2 week and 10 weeks

Secondary Measures

  • Percentage of of patients who achieve BP<140/90mmHg
    • Time Frame: Baseline and 10 weeks
  • Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10
    • Time Frame: Baseline and 10 weeks
    • Each subject will receive 24-hour ABPM at baseline and week 10.
  • Change from baseline in HBPM (Home Blood Pressure Monitor) at week 10
    • Time Frame: Baseline and 10 weeks
    • Each subject will receive HBPM at baseline, week 2, week 6 and week 10 respectively.For baseline HBPM, it was performed in the evening before visit 2 and in the morning of visit 2(before intake of study drug). in terms of the following 3 times of HBPM, they are performed during 5 days before each visit.
  • Number of patients with adverse events, serious adverse events
    • Time Frame: during 10 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy: – All treatment-naive patients need to have 140mmHg≤MSSBP<180mmHg and 90mmHg≤MSDBP< 110mmHg at visit 1 – For patients on mono antihypertensive therapy, MSSBP/MSDBP should <160/100mmHg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have MSSBP≥140 mmHg and <180mmHg AND MSDBP≥90 mmHg and <110mmHg Exclusion Criteria:

  • Severe hypertension – Malignant hypertension – Secondary hypertension – Renal dysfunction(serum creatinine > 2.0mg(176.8μmol/L)at visit 1) – Hepatic disease – History of hypertensive encephalopathy or cerebrovascular accident within 6 months – History of myocardial infarction, coronary revascularization within 6 months – Type 1 diabetes mellitus – patietns with HbA1c >8% at visit 1 – Women in pregnancy and lactation – Potentially fertile female patients not using effective contraceptive methods – Be allergy to study drug. Other protocol defined inclusion/exlusion criteria may apply

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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