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

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Valsartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals


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

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline and week 2 in blood pressure at week 10

Secondary outcome:

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

Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10

Change from baseline in HBPM (Home Blood Pressure Monitor) at week 10

Number of patients with adverse events, serious adverse events


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Locations and Contacts

Novartis Investigative Site, Beijing, Beijing 100044, China
Additional Information

Starting date: February 2012
Last updated: November 12, 2013

Page last updated: August 20, 2015

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