NCT01828359

The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.

An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 199 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.

Detailed description

* Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms). * Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges. * Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Amosartan® tab	comparison of different combination of anti-hypertension drug
DRUG	Cozaar® plus pro tab	comparison of different combination of anti-hypertension drug

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2013-04-10
• Last updated: 2013-04-10