In-practice Evaluation of Atacand 16mg Antihypertensive Effect

December 2, 2010 updated by: AstraZeneca
The purpose of this study is to prove in practice the effectiveness of Atacand 16 mg in reducing blood pressure after 4 weeks of administration and the importance of administration of adequate doses

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Latvia
      • Daugavpils, Latvia
        • Research Site
      • Jelgava, Latvia
        • Research Site
      • Liepaja, Latvia
        • Research Site
      • Riga, Latvia
        • Research Site

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

out-patient departments

Description

Inclusion Criteria:

  • Adult patients with mild (140-159/90-99 mgHg) to moderate (160-179/100-109 mmHg) essential hypertension, already treated with Atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal at least <140/90 mgHg and the doctor has decided
  • Signed and dated Patient Informed Consent (ICF)

Exclusion Criteria:

  • Hypersensitivity to the active substance or to any of the excipients of Atacand.

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

Cohorts and Interventions

Group / Cohort
1
Adult patients with mild or moderate essential hypertension who do not tolerate ACE inhibitors because of cough, already treated with Atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal and the doctor has decided to increase the Atacand dose to 16mg as per SmPC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in blood pressure
Time Frame: once after 4 weeks
once after 4 weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Agrita Hartmane, AstraZeneca

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

November 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

December 3, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CLV-ATA-2008/1

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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