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
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Valsartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541189

Locations
China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01541189     History of Changes
Other Study ID Numbers: CVAL489ACN14
Study First Received: February 23, 2012
Last Updated: November 12, 2013
Health Authority: China: Ethics Committee

Keywords provided by Novartis:
hypertension
valsartan

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014