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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01219556
First received: October 7, 2010
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
  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.


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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 9603
Study Start Date: November 2010
Study Completion Date: January 2012
Groups/Cohorts Assigned Interventions
Group 1 Drug: Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)
Oral Xirtam H tablets every 24 hours (Q24H) or as per prescribing information

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hypertension

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219556

Locations
India
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Pharmaceuticals Pvt Ltd.
ClinicalTrials.gov Identifier: NCT01219556     History of Changes
Other Study ID Numbers: 14916, XI0911IN
Study First Received: October 7, 2010
Last Updated: March 5, 2012
Health Authority: India: Drugs Controller General of India

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan medoxomil
Antihypertensive Agents
Hydrochlorothiazide
Olmesartan
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Diuretics
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

ClinicalTrials.gov processed this record on May 19, 2013