Trial Condition(s):

Hypertension

Xirtam H Combination In the treatment of hypertension Evaluation study. (XCITE)

Bayer Identifier:

14916

ClinicalTrials.gov Identifier:

NCT01219556

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.
Exclusion Criteria
- Exclusion criteria must be read in conjunction with corresponding product prescribing information

Trial Summary

Enrollment Goal
8704
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Xirtam H (Olmesartan-Hydrochlorothiazide, BAY987105)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, India

Status
Completed
 

Trial Design