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

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ClinicalTrials.gov Identifier: NCT01219556
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : January 28, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Hypertension Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)

Study Type : Observational
Actual Enrollment : 8704 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicentric, Large Scale Observational Study to Evaluate the Effectiveness & Safety of Xirtam H in Indian Patients Suffering From Hypertension.
Study Start Date : November 2010
Primary Completion Date : January 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)
Oral Xirtam H tablets every 24 hours (Q24H) or as per prescribing information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219556

Many Locations, India
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01219556     History of Changes
Other Study ID Numbers: 14916
XI0911IN ( Other Identifier: company internal )
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014

Keywords provided by Bayer:
Antihypertensive Agents
Drug Therapy, Combination
Olmesartan Medoxomil

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Olmesartan Medoxomil
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists