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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02242877
Recruitment Status : Completed
First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment
Hypertension Drug: Telmisartan Drug: Telmisartan combined with hydrochlorothiazide

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Study Type : Observational
Actual Enrollment : 3320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : February 2006
Actual Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Group/Cohort Intervention/treatment
Isolated systolic hypertension Drug: Telmisartan
Drug: Telmisartan combined with hydrochlorothiazide
Systolic and diastolic hypertension Drug: Telmisartan
Drug: Telmisartan combined with hydrochlorothiazide

Primary Outcome Measures :
  1. Normalization of arterial systolic hypertension [ Time Frame: Up to 12 weeks after start of treatment ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 55 years or older with either isolated systolic- or with systolic and diastolic hyptertension

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
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02242877    
Other Study ID Numbers: 502.510
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists