Xirtam H Combination In the Treatment of Hypertension Evaluation Study.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01219556

Acronym

XCITE

Enrollment

8704

Registered

2010-10-13

Start date

2010-11-30

Completion date

2013-02-28

Last updated

2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Antihypertensive Agents, Drug Therapy, Combination, Olmesartan Medoxomil, Hydrochlorothiazide

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.

Interventions

DRUGOlmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Exclusion criteria

Design outcomes

Primary

Measure	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

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026