Xirtam H Combination In the Treatment of Hypertension Evaluation Study.

Completed

• Conditions: Hypertension
• Interventions: Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

• Registration Number: NCT01219556
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-11
• Study First Posted: 2010-10-13
• Study Start: 2010-11
• Primary Completion: 2012-01
• Study Completion: 2013-02
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-25
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8704

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.

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with corresponding product prescribing information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)	-

Primary Outcome Measures

Name	Time	Method
Changes in seated diastolic pressure	12 weeks
Changes in seated systolic pressure	12 weeks
Achievement of target blood pressure as per Sixth Report of the Joint National Committee of High Blood Pressure (JNC-VII)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse events as measure of safety	12 weeks
Percentage of patients with satisfaction to treatment	12 weeks