Blood Pressure Lowering Effects of Amosartan Regarding Proviso iN Patients With High Blood Pressure

August 16, 2017 updated by: Dong-Ju Choi, Seoul National University Bundang Hospital

Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients With Hypertension: Prospective, Multicenter, Observational Study

Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After taking Amozatan (AMS, amlodipine / rozanthin combination) in patients with essential hypertension, the percentage of patients who reached the mean systolic target blood pressure was evaluated

Study Type

Observational

Enrollment (Actual)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Estimated total number of patients: 3,150 Estimated number of centers: 37

Description

Inclusion Criteria:

  • Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or rosartan monotherapy
  • In patients with stage 2 hypertension (SBP 160-179 mmHg), patients requiring a combination therapy to reach the target blood pressure
  • Patients who were changed to amosartan while using other hypertensive agents

Exclusion Criteria:

  • Patients with hypersensitivity to dihydropyridine derivatives of amosartan
  • Women who are pregnant or who may be pregnant and breastfeeding
  • Patients with severe hepatic dysfunction
  • Patients with severe aortic stenosis
  • Patients at risk of shock
  • Patients participating in other clinical studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with essential hypertension evaluated the mean blood pressure after taking amosartan.
Time Frame: 6 month
Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

June 30, 2015

Study Completion (ACTUAL)

December 31, 2015

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (ACTUAL)

August 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEARN BP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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