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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01541189

Collaborator

(none)

200

Enrollment

Location

Arm

Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

N/A

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 :

Feb 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline and week 2 in blood pressure at week 10 [Baseline, 2 week and 10 weeks]

Secondary Outcome Measures

Percentage of of patients who achieve BP<140/90mmHg [Baseline and 10 weeks]
Change from baseline in ABPM (Ambulatory Blood Pressure Monitor) at week 10 [Baseline and 10 weeks]
Each subject will receive 24-hour ABPM at baseline and week 10.
Change from baseline in HBPM (Home Blood Pressure Monitor) at week 10 [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.
Number of patients with adverse events, serious adverse events [during 10 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Beijing	Beijing	China	100044

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01541189

Other Study ID Numbers:

CVAL489ACN14

First Posted:

Feb 29, 2012

Last Update Posted:

Mar 21, 2017

Last Verified:

Mar 1, 2017

Keywords provided by Novartis Pharmaceuticals

hypertension

valsartan

Additional relevant MeSH terms:

Hypertension

Valsartan

Study Results

No Results Posted as of Mar 21, 2017