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OpenTrials
Completed

NCT Number: NCT01541189

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

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

valsartan

Drug

80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks

Primary outcomes

  1. Change from baseline and week 2 in blood pressure at week 10

    Time frame: Baseline, 2 week and 10 weeks

Secondary outcomes

  1. Percentage of of patients who achieve BP<140/90mmHg

    Time frame: Baseline and 10 weeks

  2. 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.

  3. 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.

  4. Number of patients with adverse events, serious adverse events

    Time frame: during 10 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 29, 2012
Registry last updated
Mar 21, 2017

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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