Clinical EvaluatioN of TElmisartan-based Antihypertensive... | NCT00613314

Status 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
Response Rate at the End of 30 Day Period	Response rate of Blood Pressure assessed in the following categories: Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline Sitting BP normalization < 130 mmHg and DBP < 85 mmHg	End of 30 day Period
Response Rate at the End of 60 Day Period	Response rate on Blood Pressure: Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline. Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline. Sitting BP normalization < 130 mmHg and DBP < 85 mmHg	At the end of 60 day period
Change in Systolic Blood Pressure (SBP) From Baseline	Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)	Baseline and 60 days
Change in Diastolic Blood Pressure (DBP) From Baseline	Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)	Baseline and 60 days

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Patients With Presence of Metabolic Risk Factor	Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely: a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities, based on patients' Medical History	At the end of 60 day period

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site		Alaminos City, Pangasinan			Philippines
Boehringer Ingelheim Investigational Site

Results Section

Participant Flow Module

ID	Title	Description
FG000	Telmisartan (Micardis)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Age summarized for 13659 subjects and 502 subjects were missing age information

Mean

Standard Deviation

Years

Title

Denominators

Categories

Sitting SBP response

Title	Measurements
	OG00041.4

Sitting DBP response

Title	Measurements
	OG00066.3

Sitting BP normalization

Primary

Response Rate at the End of 60 Day Period

Response rate on Blood Pressure:

Sitting SBP < 130 mmHg and/or a reduction of > 20 mmHg from baseline.
Sitting DBP < 85 mmHg and/or a reduction of > 10 mmHg from baseline.
Sitting BP normalization < 130 mmHg and DBP < 85 mmHg

ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Posted

Number

Percentage of patients

At the end of 60 day period

ID	Title	Description
OG000	Telmisartan (Micardis)

Units	Counts
Participants	OG00014161

Primary

Change in Systolic Blood Pressure (SBP) From Baseline

Change in SBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Posted

Mean

Standard Deviation

mmHg

Baseline and 60 days

ID	Title	Description
OG000	Telmisartan (Micardis)

Units	Counts
Participants	OG00014161

Primary

Change in Diastolic Blood Pressure (DBP) From Baseline

Change in DBP = Value in visit 1(baseline) minus value in visit 3 (at 60-day treatment period)

ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Posted

Mean

Standard Deviation

mmHg

Baseline and 60 days

ID	Title	Description
OG000	Telmisartan (Micardis)

Units	Counts
Participants	OG00014161

Secondary

Percentage of Patients With Presence of Metabolic Risk Factor

Presence of metabolic risk factor was identified by the existence of 3 out of the 5 risk factors namely:

a.) presence of diabetes mellitus; b) presence of dyslipidemia; c) presence of albuminuria; d) presence of ventricular hypertrophy; and e) presence of co-morbidities,

based on patients' Medical History

ITT Population: all patients who took at least one dose of the study medication and have at least one point treatment efficacy data available

Posted

Number

Percentage of patients

At the end of 60 day period

ID	Title	Description
OG000	Telmisartan (Micardis)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	Systematic Assessment	EG0002 affected15,268 at risk
DIARRHEA	Gastrointestinal disorders	Systematic Assessment	EG0001 affected15,268 at risk
HIGH BLOOD PRESSURE (190/120)	Investigations	Systematic Assessment	EG0001 affected15,268 at risk
MASSIVE HEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected15,268 at risk

ID	Term
D006973	Hypertension
D024821	Metabolic Syndrome

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases