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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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* 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

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Amosartan® tab

Amlodipine 5mg /Losartan 100mg

Group Type EXPERIMENTAL

Amosartan® tab

Intervention Type DRUG

comparison of different combination of anti-hypertension drug

Cozaar® plus pro tab

Losartan 100mg/ HCTZ 12.5mg

Group Type ACTIVE_COMPARATOR

Cozaar® plus pro tab

Intervention Type DRUG

comparison of different combination of anti-hypertension drug

Interventions

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Amosartan® tab

comparison of different combination of anti-hypertension drug

Intervention Type DRUG

Cozaar® plus pro tab

comparison of different combination of anti-hypertension drug

Intervention Type DRUG

Other Intervention Names

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Amlodipine 5mg /Losartan 100mg Losartan 100mg/ HCTZ 12.5mg

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No