TELSYS - TELmisartan Effectiveness in Isolated SYStolic H... | NCT02242877

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

NCT02242877

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Sep 17, 2014Estimated

Enrollment

3,320Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Telmisartan
Telmisartan combined with hydrochlorothiazide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Oct 2006Actual

Completion Date

Not provided

First Submitted Date

Sep 16, 2014

First Submission Date that Met QC Criteria

Sep 16, 2014

First Posted Date

Sep 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2014

Last Update Posted Date

Sep 17, 2014Estimated

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,320Actual

Label	Type	Description	Intervention Names
Isolated systolic hypertension			Drug: Telmisartan Drug: Telmisartan combined with hydrochlorothiazide
Systolic and diastolic hypertension			Drug: Telmisartan Drug: Telmisartan combined with hydrochlorothiazide

Name	Type	Description	Arm Group Labels	Other Names
Telmisartan	Drug		Isolated systolic hypertension Systolic and diastolic hypertension
Telmisartan combined with hydrochlorothiazide

Measure	Description	Time Frame
Normalization of arterial systolic hypertension		Up to 12 weeks after start of treatment

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D000077333	Telmisartan
D006852	Hydrochlorothiazide

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic