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

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ClinicalTrials.gov Identifier: NCT01541189
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : February 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Valsartan
80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks

Primary Outcome Measures :
  1. Change from baseline and week 2 in blood pressure at week 10 [ Time Frame: Baseline, 2 week and 10 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541189

China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01541189     History of Changes
Other Study ID Numbers: CVAL489ACN14
First Posted: February 29, 2012    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action