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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014