Additional Effect of A Life Style Program on Antihypertensive Treatment With Telmisartan

Additional Effect of a Life Style Program on Antihypertensive Treatment With Telmisartan

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01108796

Enrollment

1856

Registered

2010-04-22

Start date

2008-09-30

Completion date

2009-09-30

Last updated

2014-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

This post-marketing surveillance study is designed to supplement the data on efficacy and tolerability of Micardis® and MicardisPlus® in patients at cardiovascular risk under general practice conditions. The aim of the study is to investigate the effect of a six-month treatment with Micardis® / MicardisPlus® on blood pressure and the effect of the Lifestyle education tool for weight reduction on blood pressure control. In addition, the post-marketing surveillance study will provide information on the effects on target measurement of the Lifestyle education tool and various laboratory parameters produced by treatment with Micardis® and MicardisPlus® in an unselected patient population under general practice conditions.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with essential hypertension (blood pressure (BP) higher or equal to 140/90 mmHg or higher or equal to 130/80 mmHg in case of diabetic patients) 2. Patients with hypertension under treatment with one or more antihypertensive drug

Exclusion criteria

Patients are excluded according to the summary of product characteristics (SmPC).

Design outcomes

Primary

Measure	Time frame	Description
Changes in Mean Blood Pressure (Systolic) After Treatment, Compared to Baseline	24 weeks (Visit 1 to Visit 3)	Changes in blood pressure in patients with systolic values, measured at baseline and final visit, by treatment and by Tool/No Tool
Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline	24 weeks (Visit 1 to Visit 3)	Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool

Secondary

Measure	Time frame	Description
Changes in Laboratory Parameters: Triglycerides	24 weeks (Visit 1 to Visit 3)	Changes in the triglyceride levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Changes in Laboratory Parameters:Low Density Lipoprotein (LDL)	24 weeks (Visit 1 to Visit 3)	Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Assessment of Metabolic Effect	24 weeks (Visit 1 to Visit 3)	Metabolic effect was rated by the investigators as 'positive', 'neutral' and 'negative'
Changes in Laboratory Parameters: Blood Glucose	24 weeks (Visit 1 to Visit 3)	Changes in the fasting blood glucose levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool
Changes in Laboratory Parameters:High Density Lipoprotein (HDL)	24 weeks (Visit 1 to Visit 3)	Changes in LDL cholesterol levels from baseline to final visit in patients with both laboratory values valid, by treatment and by Tool/No Tool

Countries

Slovenia

Participant flow

Recruitment details

The aim of the study is to investigate the effect of the Lifestyle education tool (Tool/No Tool) for weight reduction on blood pressure control during a six-month treatment with Micardis® / MicardisPlus®. Patients were designated to participate or not participate in a Lifestyle education tool by the investigator under general practice conditions.

Pre-assignment details

A total of 1856 were entered into this trial and 1841 were analysed. For 15 patients case report forms were not available or not usable for analysis

Participants by arm

Arm	Count
Micardis® (Telmisartan) Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.	774
MicardisPlus® (Telmisartan Hydrochlorothiazide)	1,067
Tool (With Lifestyle Education Tool on Weight Reduction)	1,187
No Tool (Without Lifestyle Education Tool on Weight Reduction)	654
Total	3,682

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	1
Overall Study	Lost to Follow-up	7	6

Baseline characteristics

Characteristic	Micardis® (Telmisartan)	MicardisPlus® (Telmisartan Hydrochlorothiazide)	Tool (With Lifestyle Education Tool on Weight Reduction)	No Tool (Without Lifestyle Education Tool on Weight Reduction)	Total
Age, Continuous	NA Years	NA Years	61.14 Years STANDARD_DEVIATION 10.09	61.94 Years STANDARD_DEVIATION 11.01	61.43 Years STANDARD_DEVIATION 10.43
Sex/Gender, Customized Female, Micardis®/MicardisPlus®	445 Participants	624 Participants	0 Participants	0 Participants	1069 Participants
Sex/Gender, Customized Female, Tool/No Tool	0 Participants	0 Participants	679 Participants	390 Participants	1069 Participants
Sex/Gender, Customized Male, Micardis®/MicardisPlus®	328 Participants	443 Participants	0 Participants	0 Participants	771 Participants
Sex/Gender, Customized Male, Tool/No Tool	0 Participants	0 Participants	507 Participants	264 Participants	771 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 774	0 / 1,067
serious Total, serious adverse events	0 / 774	1 / 1,067

Outcome results

Primary

Changes in Mean Blood Pressure (Diastolic) After Treatment, Compared to Baseline

Changes in blood pressure in patients with diastolic values, measured at baseline and final visit, by treatment and by Tool/No Tool