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

NCT02242877 | Completed

• 1 other identifier: 502.510
• Study Type: observational
• Target: 3,320
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Normalization of arterial systolic hypertension

  Up to 12 weeks after start of treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

Isolated systolic hypertension

Drug: Telmisartan; Drug: Telmisartan combined with hydrochlorothiazide

Systolic and diastolic hypertension

Drug: Telmisartan; Drug: Telmisartan combined with hydrochlorothiazide

Interventions

Telmisartan DRUG

Isolated systolic hypertension; Systolic and diastolic hypertension

Telmisartan combined with hydrochlorothiazide DRUG

Isolated systolic hypertension; Systolic and diastolic hypertension

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 55 years or older with either isolated systolic- or with systolic and diastolic hyptertension

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Interventions

Telmisartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 17, 2014
• Study Start: February 1, 2006
• Primary Completion: October 1, 2006
• Last Updated: September 17, 2014

Record last verified: 2014-09