Xirtam H Combination In the Treatment of Hypertension Evaluation Study.

NCT01219556 | Completed

• 2 other identifiers: 14916XI0911IN
• Study Type: observational
• Target: 8,704
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Antihypertensive Agents; Drug Therapy, Combination; Olmesartan Medoxomil; Hydrochlorothiazide

Outcome Measures

Primary Outcomes (3)

• Changes in seated diastolic pressure

  12 weeks

• Changes in seated systolic pressure

  12 weeks

• Achievement of target blood pressure as per Sixth Report of the Joint National Committee of High Blood Pressure (JNC-VII)

  12 weeks

Secondary Outcomes (2)

• Number of patients with adverse events as measure of safety

  12 weeks

• Percentage of patients with satisfaction to treatment

  12 weeks

Study Arms (1)

Group 1

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

Interventions

Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105) DRUG

Oral Xirtam H tablets every 24 hours (Q24H) or as per prescribing information

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hypertension

You may qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, India

Location

MeSH Terms

Conditions

Hypertension

Interventions

olmesartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 13, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2013
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

IN (1)