Xirtam H Combination In the Treatment of Hypertension Evaluation Study.

Study Overview
=================
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.

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

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events as measure of safety |  | 12 weeks | 
| Percentage of patients with satisfaction to treatment |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Antihypertensive Agents, Drug Therapy, Combination, Olmesartan Medoxomil, Hydrochlorothiazide