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Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension

NCT02944734 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2016-11-22

No results posted yet for this study

Summary

The purpose of this study is to explore the optimal dose of fixed-dose combination of candesartan cilexetil and amlodipine besylate by examining the safety and efficacy of the combination therapy compared to each of the monotherapy in patients with essential hypertension.

Conditions

  • Essential Hypertension

Interventions

DRUG

Candesartan Cilexetil 8mg

Candesartan Cilexetil 8mg Daily oral administration for 8 weeks

DRUG

Candesartan Cilexetil 16mg

Candesartan Cilexetil 16mg Daily oral administration for 8 weeks

DRUG

Amlodipine 5mg

Amlodipine 5mg Daily oral administration for 8 weeks

DRUG

Amlodipine 10mg

Amlodipine 10mg Daily oral administration for 8 weeks

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Chong-Jin Kim · KyungHee University Hospital at Gangdong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • South Korea

Study Locations

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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 NCT02944734 on ClinicalTrials.gov