Pharmacovigilance and Patient Compliance in Hypertensive Patients

Pharmacovigilance and Patient Compliance in Hypertensive Patients. Observational Study

Study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. Furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. Additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Telmisartan

• Study Type: Observational
• Enrollment (Actual): 10333

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatients over 18 years of age suffering non-secondary, essential hypertension, treated by general practitioners and/or specialists

Description

Inclusion Criteria:

- Patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmHg (diastolic) and 140 mmHg (systolic)

Exclusion Criteria:

- corresponding to the contraindications listed in the summary of product characteristics of the drug

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with non-secondary, essential hypertension	Drug: Telmisartan; Other Names: Micardis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of changes in heart rate	Baseline, up to 8 weeks after start of treatment
Assessment for patients with changes in laboratory values	Baseline, up to 8 weeks after start of treatment
Number of patients with adverse events	Up to 8 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mean systolic and diastolic blood pressure values	Measured by means of ambulatory blood pressure monitoring (ABPM) over 24 hours	Baseline, up to 8 weeks after start of treatment
Changes in mean systolic and diastolic blood pressure values	Measured three times at intervals of two minutes with the patient seated and lying down for 5 minutes, using a sphygmomanometer	Baseline, up to 8 weeks after start of treatment
Evaluation of treatment compliance as percentage of tablets planned	(number of tablets taken / total number of days) x 100	Up to 8 weeks after start of treatment

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 1999
• Primary Completion (Actual): December 1, 2000

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Estimate): July 25, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: 502.359