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

Hanmi Pharmaceutical Company Limited199 enrolled

Overview

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.

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

199

Conditions

Hypertension

Interventions

Amosartan® tabDRUG

comparison of different combination of anti-hypertension drug

Cozaar® plus pro tabDRUG

comparison of different combination of anti-hypertension drug

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)

Time frame: Baseline, Week 8

Secondary Outcomes

Change from baseline in MSDBP

Time frame: Baseline, week 4

Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)

Time frame: Baseline, Week 4 and 8

Blood pressure responder rate

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.

Time frame: Baseline, Week 4 and 8

Data from ClinicalTrials.gov

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