Trial Condition(s):
Hypertension
Xirtam H Combination In the treatment of hypertension Evaluation study. (XCITE)
Bayer Identifier:
14916
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, India | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Prospective, multicentric, large scale observational study to evaluate the effectiveness & safety of Xirtam H in Indian patients suffering from hypertension.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Changes in seated diastolic pressureTimeframe: 12 weeks
- Changes in seated systolic pressureTimeframe: 12 weeks
- Achievement of target blood pressure as per Sixth Report of the Joint National Committee of High Blood Pressure (JNC-VII)Timeframe: 12 weeks
Secondary Outcome
- Number of patients with adverse events as measure of safetyTimeframe: 12 weeks
- Percentage of patients with satisfaction to treatmentTimeframe: 12 weeks
Additional Information
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