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

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan; Drug: Telmisartan combined with hydrochlorothiazide

• Registration Number: NCT02242877
• Lead Sponsor: Boehringer Ingelheim

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2006-10
• Status Verified: 2014-09
• Study First Submitted: 2014-09-16
• Study First Submitted QC: 2014-09-16
• Last Update Submitted: 2014-09-16
• Study First Posted: 2014-09-17
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3320

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Systolic and diastolic hypertension	Telmisartan combined with hydrochlorothiazide	-
Isolated systolic hypertension	Telmisartan combined with hydrochlorothiazide	-
Isolated systolic hypertension	Telmisartan	-
Systolic and diastolic hypertension	Telmisartan	-

Primary Outcome Measures

Name	Time	Method
Normalization of arterial systolic hypertension	Up to 12 weeks after start of treatment

Secondary Outcome Measures

Name	Time	Method
Assessment of systolic blood pressure (SBP) response	Up to 12 weeks after start of treatment
Mean decrease in systolic blood pressure	Up to 12 weeks after start of treatment
Number of patients with adverse events	Up to 12 weeks