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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01541189
First received: February 23, 2012
Last updated: November 12, 2013
Last verified: November 2013

February 23, 2012
November 12, 2013
February 2012
January 2013   (final data collection date for primary outcome measure)
Change from baseline and week 2 in blood pressure at week 10 [ Time Frame: Baseline, 2 week and 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01541189 on ClinicalTrials.gov Archive Site
  • Percentage of of patients who achieve BP<140/90mmHg [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10 [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Percentage of of patients who achieve BP<140/90mmHg [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10 [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 and death [ Time Frame: during 10 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.
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.

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Drug: Valsartan
80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks
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.
Intervention: Drug: Valsartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2013
January 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01541189
CVAL489ACN14
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP