Hypertension
Conditions
Brief summary
To assess the efficacy of telmisartan in hypertensive patients with high cardiovascular risk
Detailed description
Study Design:
Interventions
DRUGTelmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)
Telmisartan 40mg or 80mg +/- HCTZ 12.5mg or 25mg
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Hypertensive patients with BP. 140/90mmHgand high and very high cardiovascular risk according to the ESH/ESC Guidelines 2007 and in whom the prescriber has taken the decision to start treatment with telmisartan 40 or 80 mg, with or without HCTZ 12.5 mg or 25 mg, in the usual way and in line with the SmPC and reimbursement criteria
Exclusion criteria
Contra-indications as in the Summary of Product Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Blood Pressure < 140/90 mm Hg | 12 weeks | % of high risk patients with Blood Pressure \< 140/90 mm Hg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Blood Pressure Decrease | baseline and 12 weeks | systolic blood pressure |
| BP Response Rate (Drop of Systolic BP of 10mmHg or More) | 12 weeks | BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ) |
| Treatment Patterns | 12 weeks | Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications). |
| Percentage of Patients With Blood Pressure < 130/80 mm Hg | 12 weeks | — |
| Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg | 12 weeks | — |
| Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007 | 12 weeks | Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients |
| Change in Concomitant Antihypertensive Drugs Given at Study Entry | baseline and 12 weeks | Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not. |
Participant flow
Recruitment details
April 1st 2009 to January 1st 2010 recruited in 90.5% General Practitioners (GP's) and 9.5% Specialists (Sp's)
Pre-assignment details
45 patients excluded for inclusion/exclusion criteria
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | 2,913 |
| Total | 2,913 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Lost to Follow-up | 126 |
Baseline characteristics
| Characteristic | Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) |
|---|---|
| Age, Customized | 64.4 years STANDARD_DEVIATION 12.6 |
| Sex/Gender, Customized Female | 48.8 percentage of participants |
| Sex/Gender, Customized Male | 51.2 percentage of participants |
| Systolic and diastolic blood pressure Diastolic Blood Pressure | 91.9 mm Hg STANDARD_DEVIATION 8.64 |
| Systolic and diastolic blood pressure Systolic Blood Pressure | 156.1 mm Hg STANDARD_DEVIATION 12.9 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2,771 |
| serious Total, serious adverse events | 3 / 2,771 |
Outcome results
Primary
Percentage of Patients With Blood Pressure < 140/90 mm Hg
% of high risk patients with Blood Pressure \< 140/90 mm Hg
Time frame: 12 weeks
Population: Intention-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Percentage of Patients With Blood Pressure < 140/90 mm Hg | 69.6 Percentage of participants |
Secondary
Absolute Blood Pressure Decrease
systolic blood pressure
Time frame: baseline and 12 weeks
Population: Intention to treat (ITT)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Absolute Blood Pressure Decrease | 23.2 mm Hg |
Secondary
BP Response Rate (Drop of Systolic BP of 10mmHg or More)
BP response rate (drop of systolic BP of ≥ 10mmHg) after approximately 12 weeks of treatment with telmisartan (alone or in fixed combination with HCTZ)
Time frame: 12 weeks
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | BP Response Rate (Drop of Systolic BP of 10mmHg or More) | 91.85 Percentage of patients |
Secondary
Change in Concomitant Antihypertensive Drugs Given at Study Entry
Percentage of patients who had a change in concomitant antihypertensive drugs prescribed at initiation and after 12 weeks. The antihypertensive drugs were changed (which is stopped, titration of dose and started) or not.
Time frame: baseline and 12 weeks
Population: Intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Change in Concomitant Antihypertensive Drugs Given at Study Entry | 13.6 percentage of patients |
Secondary
Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg
Time frame: 12 weeks
Population: Intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Percentage of Patients in Whom the Prescriber Decide to Further Lower the Blood Pressure to < 130/80 mm Hg | 11.7 percentage of patients |
Secondary
Percentage of Patients With Blood Pressure < 130/80 mm Hg
Time frame: 12 weeks
Population: Intention to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Percentage of Patients With Blood Pressure < 130/80 mm Hg | 13.2 Percentage of participants |
Secondary
Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007
Blood pressure should be reduced to at least below 140/90 mm Hg (systolic/diastolic),and to lower values, if tolerated, in all hypertensive patients. Target blood pressure should be lower than 130/80 mmHg in diabetics and in high or very high risk patients
Time frame: 12 weeks
Population: all investigators participating in the trial
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Percentage of Prescribers Who Adhered to European Society of Hypertension/European Society of Cardiology (ESH/ESC) Guidelines 2007 | 47.7 percentage of prescribers |
Secondary
Treatment Patterns
Treatment patterns observed at the end of the study as Micardis monotherapy, Micardis Plus 12.5 and Micardis Plus 25 (with or without changes in concomitant antihypertensive medications).
Time frame: 12 weeks
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Treatment Patterns | Telmisartan 40mg | 4.7 Percentage of patients |
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Treatment Patterns | Telmisartan 80mg | 49.4 Percentage of patients |
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Treatment Patterns | Telmisartan 40/12,5mg | 3.3 Percentage of patients |
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Treatment Patterns | Telmisartan 80/12,5mg | 29.7 Percentage of patients |
| Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ) | Treatment Patterns | Telmisartan 80/25mg | 12.6 Percentage of patients |