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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Amosartan® tab; Drug: Cozaar® plus pro tab

• Registration Number: NCT01828359
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-04
• Study First Submitted: 2013-04-07
• Study First Submitted QC: 2013-04-09
• Last Update Submitted: 2013-04-09
• Study First Posted: 2013-04-10
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

• 20 aged or over
• Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs
• Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)

Exclusion Criteria

• Patients with too high Blood pressure

  •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening

• History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.

• Secondary hypertension or suspected to be

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amosartan® tab	Amosartan® tab	Amlodipine 5mg /Losartan 100mg
Cozaar® plus pro tab	Cozaar® plus pro tab	Losartan 100mg/ HCTZ 12.5mg

Primary Outcome Measures

Name	Time	Method
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)	Baseline, Week 8

Secondary Outcome Measures

Name	Time	Method
Change from baseline in MSDBP	Baseline, week 4
Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)	Baseline, Week 4 and 8
Blood pressure responder rate	Baseline, Week 4 and 8	Rate of patients who achieved target blood pressure (MSSBP \< 140 mmHg and MSDBP \< 90 mmHg), or MSSBP decrease \> 20 mmHg from baseline or MSDBP decrease \> 10 mmHg from baseline.