Xirtam H Combination In the Treatment of Hypertension Evaluation Study.

NCT ID: NCT01219556

Last Updated: 2014-01-28

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

Total Enrollment

8704 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-02-28

Brief Summary

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This is post-marketing observational study in which data on safety and effectiveness of Xirtam H will be collected from routine clinical practice. The study objectives are to investigate the effect of Xirtam-H on blood pressure and achievement of target blood pressure as well as safety and satisfaction of treatment. All hypertensive patients (Blood pressure \> 140/90 mmHg) where investigator feels that addition of Xirtam H would be beneficial to patients will be included in non interventional study. The routine investigation suggested by the attending physician will be done in patients of hypertension. No additional investigation will be done for the study purpose. The patient not controlled on existing treatment and prescribed Xirtam H will be included in study after taking the informed consent. The patient will be followed up for 2-follow up visit each after 6 weeks. The physical examination, routine investigation, blood pressure measures will be done and the data will be entered in the CRF as mentioned in CRF in each visit. The study is planned to be carried out in 9604 patients from around 300 - 350 trial sites in India.

Detailed Description

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Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

Intervention Type DRUG

Oral Xirtam H tablets every 24 hours (Q24H) or as per prescribing information

Interventions

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Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

Oral Xirtam H tablets every 24 hours (Q24H) or as per prescribing information

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All Indian hypertensive patients (Blood pressure \> 140/90 mm Hg) where investigator feels that addition of Xirtam H would be beneficial to patients will be included in non interventional study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , India

Site Status

Countries

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India

Other Identifiers

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XI0911IN

Identifier Type: OTHER

Identifier Source: secondary_id

14916

Identifier Type: -

Identifier Source: org_study_id

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