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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

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ClinicalTrials.gov Identifier: NCT00904371
Recruitment Status : Completed
First Posted : May 19, 2009
Results First Posted : August 21, 2012
Last Update Posted : August 21, 2012
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Hypertension
Cardiovascular Diseases
Enrollment 211
Recruitment Details  
Pre-assignment Details Phase IV, Post Marketing Surveillance Study, non-interventional, multicentre, national, observational study in routine daily practice.
Arm/Group Title Micardis® 80mg; MicardisPlus® 80/12.5 mg
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 211
Completed 202
Not Completed 9
Reason Not Completed
Adverse Event             2
Lost to Follow-up             4
Discontinued at target blood pressure             2
Continued with Tritace             1
Arm/Group Title Micardis® 80mg; MicardisPlus® 80/12.5 mg
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 211
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 211 participants
64.4  (10.4)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 211 participants
Female 90
Male 113
[1]
Measure Description: There were only 203 patients with non-missing gender
Additional antihypertensive treatment at baseline   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 211 participants
ACE inhibitors 19
Diuretics 15.2
Calcium Channel Blockers 26.5
Beta Blockers 39.3
Other 7.6
[1]
Measure Description: Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.
1.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP)
Hide Description [Not Specified]
Time Frame Baseline to 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data both at baseline and on 3rd visit (4-10 months)
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 204
Mean (Standard Deviation)
Unit of Measure: mm Hg
-22.6  (17.1)
2.Primary Outcome
Title Change From Baseline in Diastolic Blood Pressure (DBP)
Hide Description [Not Specified]
Time Frame Baseline to 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data both at baseline and on 3rd visit (4-10 months)
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 203
Mean (Standard Deviation)
Unit of Measure: mm Hg
-10.1  (10.1)
3.Primary Outcome
Title Change From Baseline in SCORE (10 Year Risk for Fatal Cardiovascular Event)
Hide Description A 10 year risk of fatal cardiovascular disease (CVD) in populations at high risk. Minimum 0 percent risk to Maximum 47 percent risk.
Time Frame Baseline to 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data both at baseline and on 3rd visit (4-10 months)
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 172
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.9  (8.8)
4.Primary Outcome
Title Change From Baseline in Framingham CVD Risk Assessment Score
Hide Description 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).
Time Frame Baseline to 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data both at baseline and on 3rd visit (4-10 months)
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 148
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.6  (8.6)
5.Primary Outcome
Title Change From Baseline in Framingham Stroke Risk Assessment Score
Hide Description 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).
Time Frame Baseline to 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data both at baseline and on 3rd visit (4-10 months)
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 146
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.6  (8.0)
6.Primary Outcome
Title Change From Baseline in Risk Assessment According to ESH/ESC Guidelines
Hide Description ESH is the European society of hypertension, and ESC is the European society of cardiology.
Time Frame Baseline to 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data both at baseline and on 3rd visit (4-10 months)
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 139
Measure Type: Number
Unit of Measure: Participants moved into category
Average risk 18
Low added risk 7
Moderate added risk -13
Very high added risk -12
7.Secondary Outcome
Title Pecentage of Patients That Achieved Target Blood Pressure (BP) Values According to ESH/ESC
Hide Description 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
Time Frame 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data at 3rd visit (4-10 months)
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 195
Measure Type: Number
Unit of Measure: Percentage of participants
Achieved target BP values 32.8
Not achieved target BP values 67.2
8.Secondary Outcome
Title Additional Antihypertensive Treatment Pattern at Visit 3 (End of Study)
Hide Description Participants may have taken more than one antihypertensive treatment, so the percentages will not add to 100 percent.
Time Frame 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data at 3rd visit (4-10 months)
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 205
Measure Type: Number
Unit of Measure: Percentage of participants
ACE inhibitors 19
Diuretics 11.2
Calcium Channel Blockers 32.2
Beta Blockers 36.1
Other 9.3
9.Secondary Outcome
Title Change in Heart Rate From Baseline to Study End
Hide Description [Not Specified]
Time Frame Baseline to 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data both at baseline and on 3rd visit (4-10 months) and known diabetic status
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 156
Mean (Standard Deviation)
Unit of Measure: Beats per minute
-3.2  (9.2)
10.Secondary Outcome
Title Number of Patients With Adverse Events (AE)
Hide Description [Not Specified]
Time Frame 4-10 months
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: Participants
4
11.Secondary Outcome
Title Number of Participants Not Completing Study
Hide Description Number of participants discontinuing study early for given reason
Time Frame 3rd visit (4-10 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data at 3rd visit (4-10 months)
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 211
Measure Type: Number
Unit of Measure: Participants
Adverse Event 2
Lost to follow up 4
Discontinued at target BP 2
Continued with Tritace 1
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Micardis® 80mg MicardisPlus® 80/12.5 mg
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Micardis® 80mg MicardisPlus® 80/12.5 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Micardis® 80mg MicardisPlus® 80/12.5 mg
Affected / at Risk (%)
Total   2/211 (0.95%) 
Immune system disorders   
Lip oedema  1  1/211 (0.47%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoma in situ  1  1/211 (0.47%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Micardis® 80mg MicardisPlus® 80/12.5 mg
Affected / at Risk (%)
Total   0/211 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00904371     History of Changes
Other Study ID Numbers: 502.585
First Submitted: May 18, 2009
First Posted: May 19, 2009
Results First Submitted: June 27, 2012
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012