Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-27 @ 5:49 PM
Study NCT ID:
NCT01828359
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2013-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.
Sponsor:
Hanmi Pharmaceutical Company Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: