Telmisartan 80mg+Hydrochlorothiazide (HCTZ) 25 mg in Hype... | NCT00909038

Official Title

A Descriptive Pharmaco-epidemiological Study of a Hypertensive Patient Population Treated With a Fixed-dose Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg and of Conditions for the Management of Arterial Hypertension

Status Module

Sponsor/Collaborators Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of BP Control in Hypertensive Patients	Percentage of controlled Patients at the Study End. Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) <140/90 mmHg for unselected hypertensive patients and SBP and DBP <130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines.	Baseline to a minimum of 8 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population	Mean SBP measured at the Study End	baseline to a minimum of 8 weeks of treatment
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigator site 1		Ablon-sur-Seine			France
Boehringer Ingelheim Investigator site 2

Results Section

Participant Flow Module

ID	Title	Description
FG000	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg	Patients treated at least 8 weeks with Fixed Dose Combination (FDC)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.5± 10.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000835
Male	BG0001159

Hypertension treatments prescribed prior to initiation of treatment

Hypertension treatments prescribed prior to initiation of treatment with telmisartan 80mg in a FDC with HCTZ 25 mg

Number

Percentage of participants

Title

Denominators

Categories

Angiotensin II antagonist

Title	Measurements
	BG00071.8

Diuretic

Title	Measurements
	BG000

Conditions for prescribing 80 mg telmisartan in fixed combination with 25 mg HCTZ

Conditions for prescribing 80 mg telmisartan in fixed combination with 25 mg HCTZ were ,

"Lack of efficacy of previous treatments" and "To decrease the number of treatment administration throughout the day"

Number

Percentage of participants

Title

Denominators

Categories

Lack of efficacy

Title	Measurements
	BG00053.8

To decrease the number of treatment

Title	Measurements

Cardiovascular risk factors (including the existence of a metabolic syndrome)

Number of Patients used in the analysis for Cardiovascular risk factors (including the existence of a metabolic syndrome) were 322 Participants with existence of a metabolic syndrome

Number

Percentage of participants

Title

Denominators

Categories

Age (male>50 or female>60)

Title	Measurements
	BG00082.0

Smoking

Title	Measurements

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Rate of BP Control in Hypertensive Patients

Percentage of controlled Patients at the Study End.

Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) <140/90 mmHg for unselected hypertensive patients and SBP and DBP <130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines.

Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.

Posted

Number

95% Confidence Interval

Percentage of Participants

Baseline to a minimum of 8 weeks of treatment

ID	Title	Description
OG000	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg	Patients treated at least 8 weeks with Fixed Dose Combination (FDC)

Units	Counts
Participants	OG0001994

Title

Denominators

Categories

Title	Measurements
	OG00051.3(49.0 to 53.5)

Secondary

Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population

Mean SBP measured at the Study End

Posted

Mean

Standard Deviation

mm Hg

baseline to a minimum of 8 weeks of treatment

ID	Title	Description
OG000	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg	Patients treated at least 8 weeks with Fixed Dose Combination (FDC)

Units	Counts
Participants	OG000

Secondary

Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population

Mean DBP measured at the Study End

Posted

Mean

Standard Deviation

mm Hg

baseline to a minimum of 8 weeks of treatment

ID	Title	Description
OG000	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg	Patients treated at least 8 weeks with Fixed Dose Combination (FDC)

Units	Counts
Participants	OG000

Secondary

Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk

Mean SBP measured at the Study End

Posted

Mean

Standard Deviation

mmHg

baseline to a minimum of 8 weeks of treatment

ID	Title	Description
OG000	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg	Patients treated at least 8 weeks with Fixed Dose Combination (FDC)

Units	Counts
Participants	OG000

Secondary

Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk

Mean DBP measured at the Study End

Posted

Mean

Standard Deviation

mmHg

baseline to a minimum of 8 weeks of treatment

ID	Title	Description
OG000	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg	Patients treated at least 8 weeks with Fixed Dose Combination (FDC)

Units	Counts
Participants	OG000

Secondary

Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007

The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.

Per protocol set (PPS)

Posted

Number

percentage of patients

Baseline to a minimum of 8 weeks of treatment

ID	Title	Description
OG000	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg	Patients treated at least 8 weeks with Fixed Dose Combination (FDC)

Units	Counts
Participants	OG000661

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg	Patients treated at least 8 weeks with Fixed Dose Combination (FDC)			0	1,994	0	1,994

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases