Double-dose Valsartan Monotherapy in Hypertension Treatme... | NCT01541189

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

NCT01541189

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Mar 21, 2017Actual

Enrollment

200Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

Valsartan

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Feb 23, 2012

First Submission Date that Met QC Criteria

Feb 28, 2012

First Posted Date

Feb 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2017

Last Update Posted Date

Mar 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
valsartan	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Valsartan	Drug	80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks	valsartan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline and week 2 in blood pressure at week 10		Baseline, 2 week and 10 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	Each subject will receive 24-hour ABPM at baseline and week 10.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Beijing	Beijing Municipality	100044	China

ID	Term
D006973	Hypertension

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000068756	Valsartan

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided