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Completed

NCT Number: NCT02242877

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

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)

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Key information

Age range

55 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

  • 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

Treatment and study plan

Telmisartan

Drug

Telmisartan combined with hydrochlorothiazide

Drug

Primary outcomes

  1. Normalization of arterial systolic hypertension

    Time frame: Up to 12 weeks after start of treatment

Secondary outcomes

  1. Assessment of systolic blood pressure (SBP) response

    Time frame: Up to 12 weeks after start of treatment

  2. Mean decrease in systolic blood pressure

    Time frame: Up to 12 weeks after start of treatment

  3. Number of patients with adverse events

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Observational Study in Everyday Medical Practice of the Effectiveness of Telmisartan for Treatment of Isolated Systolic Hypertension in Comparison With Systolic/Diastolic Hypertension in Patients Aged 55 or Older

Acronym: TELSYS

Important dates

Study start
2006
Primary completion
2006
First posted
Sep 17, 2014
Registry last updated
Sep 17, 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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