Trial Outcomes & Findings for Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients (NCT NCT00904371)

NCT ID: NCT00904371

Last Updated: 2012-08-21

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 211 participants
• Primary outcome timeframe: Baseline to 3rd visit (4-10 months)
• Results posted on: 2012-08-21

Participant Flow

Phase IV, Post Marketing Surveillance Study, non-interventional, multicentre, national, observational study in routine daily practice.

Participant milestones

Measure	Micardis® 80mg; MicardisPlus® 80/12.5 mg
Overall Study STARTED	211
Overall Study COMPLETED	202
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Micardis® 80mg; MicardisPlus® 80/12.5 mg
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	4
Overall Study Discontinued at target blood pressure	2
Overall Study Continued with Tritace	1

Baseline Characteristics

Evaluation of the Effect of Telmisartan (Micardis® 80 mg/ MicardisPlus® 80/12.5 mg) on Blood Pressure and Cardiovascular Risk Factor Index in High Risk Hypertensive Patients

Baseline characteristics by cohort

Measure	Micardis® 80mg; MicardisPlus® 80/12.5 mg n=211 Participants
Age Continuous	64.4 years STANDARD_DEVIATION 10.4 • n=5 Participants
Gender Female	90 Participants n=5 Participants
Gender Male	113 Participants n=5 Participants
Additional antihypertensive treatment at baseline ACE inhibitors	19 Percentage of participants n=5 Participants
Additional antihypertensive treatment at baseline Diuretics	15.2 Percentage of participants n=5 Participants
Additional antihypertensive treatment at baseline Calcium Channel Blockers	26.5 Percentage of participants n=5 Participants
Additional antihypertensive treatment at baseline Beta Blockers	39.3 Percentage of participants n=5 Participants
Additional antihypertensive treatment at baseline Other	7.6 Percentage of participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3rd visit (4-10 months)

Population: Patients with data both at baseline and on 3rd visit (4-10 months)

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=204 Participants
Change From Baseline in Systolic Blood Pressure (SBP)	-22.6 mm Hg Standard Deviation 17.1

PRIMARY outcome

Timeframe: Baseline to 3rd visit (4-10 months)

Population: Patients with data both at baseline and on 3rd visit (4-10 months)

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=203 Participants
Change From Baseline in Diastolic Blood Pressure (DBP)	-10.1 mm Hg Standard Deviation 10.1

PRIMARY outcome

Timeframe: Baseline to 3rd visit (4-10 months)

Population: Patients with data both at baseline and on 3rd visit (4-10 months)

A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=172 Participants
Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)	-3.9 units on a scale Standard Deviation 8.8

PRIMARY outcome

Timeframe: Baseline to 3rd visit (4-10 months)

Population: Patients with data both at baseline and on 3rd visit (4-10 months)

10-year risk for hard coronary heart disease (CHD) outcomes (Myocardial Infarction and coronary death), according to Framingham Heart Study, measured in percent. Low risk (10 or less CHD risk at 10 years), intermediate risk (10-20), high risk (20 or more).

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=148 Participants
Change From Baseline in Framingham CVD Risk Assessment Score	-7.6 units on a scale Standard Deviation 8.6

PRIMARY outcome

Timeframe: Baseline to 3rd visit (4-10 months)

Population: Patients with data both at baseline and on 3rd visit (4-10 months)

The risk assessment tool using data from the Framingham Heart Study to estimate 10-year risk for stroke, measured in percent. Low risk (10 or less stroke risk at 10 years), intermediate risk (10-20), high risk (20 or more).

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=146 Participants
Change From Baseline in Framingham Stroke Risk Assessment Score	-3.6 units on a scale Standard Deviation 8.0

PRIMARY outcome

Timeframe: Baseline to 3rd visit (4-10 months)

Population: Patients with data both at baseline and on 3rd visit (4-10 months)

ESH is the European society of hypertension, and ESC is the European society of cardiology.

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=139 Participants
Change From Baseline in Risk Assessment According to ESH/ESC Guidelines Average risk	18 Participants moved into category
Change From Baseline in Risk Assessment According to ESH/ESC Guidelines Low added risk	7 Participants moved into category
Change From Baseline in Risk Assessment According to ESH/ESC Guidelines Moderate added risk	-13 Participants moved into category
Change From Baseline in Risk Assessment According to ESH/ESC Guidelines Very high added risk	-12 Participants moved into category

SECONDARY outcome

Timeframe: 3rd visit (4-10 months)

Population: Patients with data at 3rd visit (4-10 months)

ESH/ESC a goal of treatment to be below values 130/80 mm/Hg for diabetic patients and below 140/90 mmHg for non-diabetic patients

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=195 Participants
Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC Achieved target BP values	32.8 Percentage of participants
Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC Not achieved target BP values	67.2 Percentage of participants

SECONDARY outcome

Timeframe: 3rd visit (4-10 months)

Population: Patients with data at 3rd visit (4-10 months)

Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=205 Participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) Diuretics	11.2 Percentage of participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) Calcium Channel Blockers	32.2 Percentage of participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) Beta Blockers	36.1 Percentage of participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) Other	9.3 Percentage of participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) ACE inhibitors	19 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to 3rd visit (4-10 months)

Population: Patients with data both at baseline and on 3rd visit (4-10 months) and known diabetic status

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=156 Participants
Change in Heart Rate From Baseline to Study End	-3.2 Beats per minute Standard Deviation 9.2

SECONDARY outcome

Timeframe: 4-10 months

Population: Treated patients

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=211 Participants
Number of Patients With Adverse Events (AE)	4 Participants

SECONDARY outcome

Timeframe: 3rd visit (4-10 months)

Population: Patients with data at 3rd visit (4-10 months)

Number of participants discontinuing study early for given reason

Outcome measures

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=211 Participants
Number of Participants Not Completing Study Adverse Event	2 Participants
Number of Participants Not Completing Study Lost to follow up	4 Participants
Number of Participants Not Completing Study Discontinued at target BP	2 Participants
Number of Participants Not Completing Study Continued with Tritace	1 Participants

Adverse Events

Micardis® 80mg MicardisPlus® 80/12.5 mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Micardis® 80mg MicardisPlus® 80/12.5 mg n=211 participants at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ	0.47% 1/211 • 6 months
Immune system disorders Lip oedema	0.47% 1/211 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER