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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Notify MeKey information
Conditions
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 combined with hydrochlorothiazide
DrugPrimary outcomes
-
Normalization of arterial systolic hypertension
Time frame: Up to 12 weeks after start of treatment
Secondary outcomes
-
Assessment of systolic blood pressure (SBP) response
Time frame: Up to 12 weeks after start of treatment
-
Mean decrease in systolic blood pressure
Time frame: Up to 12 weeks after start of treatment
-
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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