check_circleStudy Completed

Hypertension

Bayer Identifier:

14916

ClinicalTrials.gov Identifier:

NCT01219556

EudraCT Number:

Not Available

EU CT Number:

Not Available
Xirtam H Combination In the treatment of hypertension Evaluation study.

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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 must be read in conjunction with corresponding product prescribing information

Trial summary

Enrollment Goal
8704
Trial Dates
November 2010 - February 2013
Phase
N/A
Could I Receive a placebo
No
Products
Xirtam H (Olmesartan-Hydrochlorothiazide, BAY987105)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, India

Primary Outcome

  • Changes in seated diastolic pressure
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    No
  • Changes in seated systolic pressure
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    No
  • Achievement of target blood pressure as per Sixth Report of the Joint National Committee of High Blood Pressure (JNC-VII)
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    No

Secondary Outcome

  • Number of patients with adverse events as measure of safety
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    Yes
  • Percentage of patients with satisfaction to treatment
    date_rangeTime Frame:
    12 weeks
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    Safety Issue:
    No

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
N/A

Additional Information

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