Pharmacovigilance and Patient Compliance in Hypertensive Patients

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan

• Registration Number: NCT02200575
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-05
• Primary Completion: 2000-12
• Status Verified: 2014-07
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Last Update Submitted: 2014-07-24
• Study First Posted: 2014-07-25
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10333

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with non-secondary, essential hypertension	Telmisartan	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in mean systolic and diastolic blood pressure values	Baseline, up to 8 weeks after start of treatment	Measured three times at intervals of two minutes with the patient seated and lying down for 5 minutes, using a sphygmomanometer
Evaluation of treatment compliance as percentage of tablets planned	Up to 8 weeks after start of treatment	(number of tablets taken / total number of days) x 100