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Completed

NCT Number: NCT01219556

Xirtam H Combination In the Treatment of Hypertension Evaluation Study.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

Drug

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

Primary outcomes

  1. Changes in seated diastolic pressure

    Time frame: 12 weeks

  2. Changes in seated systolic pressure

    Time frame: 12 weeks

  3. Achievement of target blood pressure as per Sixth Report of the Joint National Committee of High Blood Pressure (JNC-VII)

    Time frame: 12 weeks

Secondary outcomes

  1. Number of patients with adverse events as measure of safety

    Time frame: 12 weeks

  2. Percentage of patients with satisfaction to treatment

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: XCITE

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Oct 13, 2010
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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