XCITE: Xirtam H Combination In the Treatment of Hypertension Evaluation Study.

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01219556

Collaborator

(none)

8,704

Enrollment

Location

Duration (Months)

321.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

Study Design

Study Type:

Observational

Actual Enrollment :

8704 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective, Multicentric, Large Scale Observational Study to Evaluate the Effectiveness & Safety of Xirtam H in Indian Patients Suffering From Hypertension.

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Group 1	Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105) Oral Xirtam H tablets every 24 hours (Q24H) or as per prescribing information

Arm

Intervention/Treatment

Group 1

Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

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

Outcome Measures

Primary Outcome Measures

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

Number of patients with adverse events as measure of safety [12 weeks]
Percentage of patients with satisfaction to treatment [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.