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Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine

NCT01663233 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2015-10-23

Study results available
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Summary

This study will assess whether LCZ696 when used in combination with amlodipine will provide greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not adequately responsive to amlodipine therapy.

Conditions

  • Essential Hypertension

Interventions

DRUG

LCZ696

LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day.

DRUG

Amlodipine

Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.

DRUG

Placebo

Matching placebo to LCZ696

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • China
  • Japan
  • Malaysia
  • Philippines
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01663233 on ClinicalTrials.gov