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OpenTrials
Completed

NCT Number: NCT02200575

Pharmacovigilance and Patient Compliance in Hypertensive Patients

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.

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telmisartan

Drug

Other names: Micardis®

Primary outcomes

  1. Assessment of changes in heart rate

    Time frame: Baseline, up to 8 weeks after start of treatment

  2. Assessment for patients with changes in laboratory values

    Time frame: Baseline, up to 8 weeks after start of treatment

  3. Number of patients with adverse events

    Time frame: Up to 8 weeks after start of treatment

Secondary outcomes

  1. Changes in mean systolic and diastolic blood pressure values

    Time frame: Baseline, up to 8 weeks after start of treatment

    Measured by means of ambulatory blood pressure monitoring (ABPM) over 24 hours

  2. Changes in mean systolic and diastolic blood pressure values

    Time frame: 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

  3. Evaluation of treatment compliance as percentage of tablets planned

    Time frame: Up to 8 weeks after start of treatment

    (number of tablets taken / total number of days) x 100

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Pharmacovigilance and Patient Compliance in Hypertensive Patients. Observational Study

Important dates

Study start
1999
Primary completion
2000
First posted
Jul 25, 2014
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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