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

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Bayer

Status

Completed

Conditions

Hypertension

Treatments

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

Study type

Observational

Funder types

Industry

Identifiers

NCT01219556
14916
XI0911IN (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

8,704 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

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

Trial design

8,704 participants in 1 patient group

Group 1
Treatment:
Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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