Many Locations, India
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
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)
DrugOral Xirtam H tablets every 24 hours (Q24H) or as per prescribing information
Primary outcomes
-
Changes in seated diastolic pressure
Time frame: 12 weeks
-
Changes in seated systolic pressure
Time frame: 12 weeks
-
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
-
Number of patients with adverse events as measure of safety
Time frame: 12 weeks
-
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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