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

NCT01541189 | Completed Phase 4

• 1 other identifier: CVAL489ACN14
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

hypertension; valsartan

Outcome Measures

Primary Outcomes (1)

• Change from baseline and week 2 in blood pressure at week 10

  Baseline, 2 week and 10 weeks

Secondary Outcomes (4)

• 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

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

  Baseline and 10 weeks

• Number of patients with adverse events, serious adverse events

  during 10 weeks

Study Arms (1)

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

Valsartan DRUG

80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks

valsartan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: February 29, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 21, 2017

Record last verified: 2017-03

Locations

CN (1)