Trial Outcomes & Findings for Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients (NCT NCT01108809)

NCT ID: NCT01108809

Last Updated: 2014-03-28

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 295 participants
• Primary outcome timeframe: From baseline to visit 3 (6 months)
• Results posted on: 2014-03-28

Participant Flow

Participant milestones

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg
Overall Study STARTED	295
Overall Study COMPLETED	291
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	1

Baseline Characteristics

Evaluation of the Effect of Telmisartan on Blood Pressure Control of High Risk Patients

Baseline characteristics by cohort

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=295 Participants
Age, Continuous	61.9 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	172 Participants n=5 Participants
Sex: Female, Male Male	123 Participants n=5 Participants
Systolic Blood Pressure (mean)	171 mmHg STANDARD_DEVIATION 16.2 • n=5 Participants
Diastolic Blood Pressure (mean)	97 mmHg STANDARD_DEVIATION 10.4 • n=5 Participants
Heart Rate	79 beats/minute STANDARD_DEVIATION 11.5 • n=5 Participants
Additional antihypertensive treatment at baseline ACE inhibitors	53.1 Percentage of participants n=5 Participants
Additional antihypertensive treatment at baseline Diuretics	58.6 Percentage of participants n=5 Participants
Additional antihypertensive treatment at baseline Calcium Channel Blockers	35.1 Percentage of participants n=5 Participants
Additional antihypertensive treatment at baseline Beta Blockers	61.9 Percentage of participants n=5 Participants
Additional antihypertensive treatment at baseline Other	15.5 Percentage of participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to visit 3 (6 months)

Population: Patients with data both at baseline and on 3rd visit

Outcome measures

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=292 Participants
Change in Systolic Blood Pressure From Baseline to Study End	-39.2 mmHg Standard Deviation 6.6

PRIMARY outcome

Timeframe: From baseline to visit 3 (6 months)

Population: Patients with data both at baseline and on 3rd visit

Outcome measures

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=292 Participants
Change in Diastolic Blood Pressure From Baseline to Study End	-17.8 mmHg Standard Deviation 2.8

PRIMARY outcome

Timeframe: From baseline to visit 3 (6 months)

Population: Patients with data both at baseline and on 3rd visit

A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk. Investigator judgement of evolution of SCORE from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

Outcome measures

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=295 Participants
Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End Positive	64.8 Percentage of participants
Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End Neutral	8.8 Percentage of participants
Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End Negative	0.3 Percentage of participants
Evolution of the Cardiovascular Risk Factor SCORE From Baseline to Study End Missing	26.1 Percentage of participants

PRIMARY outcome

Timeframe: From baseline to visit 3 (6 months)

Population: Patients with data both at baseline and on 3rd visit

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). Investigator judgement of evolution of Framingham risk score from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

Outcome measures

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=295 Participants
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End Positive	58.3 Percentage of participants
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End Neutral	10.2 Percentage of participants
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End Negative	0.3 Percentage of participants
Evolution of the Cardiovascular Risk Factor Framingham From Baseline to Study End Missing	31.2 Percentage of participants

PRIMARY outcome

Timeframe: From baseline to visit 3 (6 months)

Population: Patients with data both at baseline and on 3rd visit

ESH is the European society of hypertension, and ESC is the European society of cardiology. Investigator judgement of evolution of CV risk based on ESH/ ESC criteria from baseline to end of study. (Positive = reduction in CV risk; Neutral = no change in CV risk; Negative = deterioration in CV risk; Missing = no data available)

Outcome measures

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=295 Participants
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End Positive	65.1 Percentage of participants
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End Neutral	12.9 Percentage of participants
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End Negative	0.3 Percentage of participants
Evolution of the European Society of Hypertension / European Society of Cardiology (ESH/ESC) Based Cardiovascular Risk Factor From Baseline to Study End Missing	21.7 Percentage of participants

SECONDARY outcome

Timeframe: Visit 3 (6 months from baseline)

Population: Patients with data at 3rd visit

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® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=295 Participants
Percentage of Patients That Achieve Target Blood Pressure Values According to the European Society of Hypertension/European Society of Cardiology (ESH/ESC)	57.3 Percentage of participants

SECONDARY outcome

Timeframe: 6 Months

Population: Patients with data at 3rd visit

Outcome measures

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=201 Participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) ACE inhibitors	16.9 Percentage of participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) Diuretics	34.8 Percentage of participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) Calcium Channel Blockers	39.3 Percentage of participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) Beta Blockers	75.1 Percentage of participants
Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study) Other	20.9 Percentage of participants

SECONDARY outcome

Timeframe: From baseline to visit 3 (6 months)

Population: Patients with data both at baseline and on 3rd visit

Outcome measures

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=269 Participants
Change in Heart Rate From Baseline to Study End	-7.6 beats / minute Standard Deviation 3.9

SECONDARY outcome

Timeframe: 3rd visit (6 months)

Population: Patients with data at 3rd visit

Number of participants discontinuing study early for given reason

Outcome measures

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=295 Participants
Number of Participants Not Completing Study Adverse Event	3 Number of participants
Number of Participants Not Completing Study Lost to follow up	1 Number of participants

SECONDARY outcome

Timeframe: 6 months

Population: Treated patients

Outcome measures

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=295 Participants
Number of Patients With Adverse Events (AE)	4 Number of participants

Adverse Events

Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg n=295 participants at risk
General disorders Generalized angioedema	0.34% 1/295 • 24 weeks

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
• Publication restrictions are in place