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Xirtam H Combination In the Treatment of Hypertension Evaluation Study.

NCT01219556 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8704

Last updated 2014-01-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-01-31
Completion
2013-02-28

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01219556 on ClinicalTrials.gov