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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01219556
First received: October 7, 2010
Last updated: January 25, 2014
Last verified: January 2014

October 7, 2010
January 25, 2014
November 2010
January 2012   (final data collection date for primary outcome measure)
  • Changes in seated diastolic pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes in seated systolic pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Achievement of target blood pressure as per Sixth Report of the Joint National Committee of High Blood Pressure (JNC-VII) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01219556 on ClinicalTrials.gov Archive Site
  • Number of patients with adverse events as measure of safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with satisfaction to treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Xirtam H Combination In the Treatment of Hypertension Evaluation Study.
Prospective, Multicentric, Large Scale Observational Study to Evaluate the Effectiveness & Safety of Xirtam H in Indian Patients Suffering From Hypertension.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Hypertension

Hypertension
Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)
Oral Xirtam H tablets every 24 hours (Q24H) or as per prescribing information
Group 1
Intervention: Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8704
February 2013
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01219556
14916, XI0911IN
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP