TELSYS - TELmisartan Effectiveness in Isolated SYStolic Hypertension Versus Systolic/Diastolic Hypertension Patients Aged 55 or Older

NCT ID: NCT02242877

Last Updated: 2014-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28

Brief Summary

The aim of this study is to compare the effect of treatment with telmisartan on patients in whom the systolic BP is approximately 12 weeks after starting treatment under control for the first time between patients with isolated systolic hypertension (ISH) at the beginning to patients with systolic/diastolic hypertension (SDH)

Conditions

Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Isolated systolic hypertension

Telmisartan

Intervention Type: DRUG

Telmisartan combined with hydrochlorothiazide

Intervention Type: DRUG

Systolic and diastolic hypertension

Telmisartan

Intervention Type: DRUG

Telmisartan combined with hydrochlorothiazide

Intervention Type: DRUG

Interventions

Telmisartan

Intervention Type: DRUG

Telmisartan combined with hydrochlorothiazide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 55, with no upper limit
• Patient who has been treated and followed up for more than 12 months by the same general practitioner (GP)
• Hypertension measured at least once during the past 12 months and not under control at the time of inclusion in the study:

• isolated systolic hypertension, namely systolic blood pressure ≥ 140 mmHg and diastolic blood pressure < 90 mmHg or
• systolic/diastolic hypertension, namely systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg; or
• systolic blood pressure ≥ 130 and diastolic blood pressure ≥ 80 mmHg, if the patient has diabetes or chronic renal insufficiency
• Treatment with one or more antihypertensives which remains unchanged during the month prior to collecting the data
• Decision by the GP to add telmisartan (either in combination with hydrochlorothiazide (HCTZ) or not) to the antihypertensive treatment; this decision is made by the treating doctor regardless of participation in the study. The prescription is issued in the normal way, in accordance with the conditions set down in the marketing authorisation
• Written informed consent of the patient to collect his/her data

Exclusion Criteria

• The patient refuses to allow his/her data to be collected
• Change in the antihypertensive treatment during the month prior to collection of the data
• Blood pressure under control
• The recommended target values corresponding to control of diastolic and systolic blood pressure are important because of the diseases associated with hypertension consequently, and in order to prevent the collection process becoming too complicated, data from patients with severe renal insufficiency or with proteinuria of ≥ 1 g/L or more are not collected in the context of this study

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

502.510

Identifier Type: -

Identifier Source: org_study_id