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Trial record 56 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659607
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : October 22, 2009
Last Update Posted : June 6, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Observational
Study Design Time Perspective: Prospective
Condition Hypertension
Enrollment 6901
Recruitment Details A total of 6,901 Case Report Forms were retrieved from 281 study centers. Three thousand and nine hundred thirty two (3,932) patients were eligible for the safety assessment. As requested by KFDA to be in line with the registered indication, 2, 969 patients with mild hypertension and treatment naïve patients were excluded from analysis.
Pre-assignment Details  
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
Period Title: Overall Study
Started 3932
Completed 3616
Not Completed 316
Reason Not Completed
No blood pressure recorded             147
Unknown measuring date of blood pressure             85
‘Unable to evaluate’ for the final asses             67
No recorded efficacy data             15
Inconsistent BP measuring date             2
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
Overall Number of Baseline Participants 3917
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3917 participants
60  (12)
[1]
Measure Description: Date of birth not recorded for 15 patients,
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3917 participants
Female
2057
  52.5%
Male
1860
  47.5%
[1]
Measure Description: Gender not recorded for 15 patients
1.Primary Outcome
Title Unexpected Adverse Events
Hide Description Occurrence status of unexpected adverse events
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
Overall Number of Participants Analyzed 3932
Measure Type: Number
Unit of Measure: Percentage of patients
0.58
2.Primary Outcome
Title Frequency of Adverse Events
Hide Description [Not Specified]
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
Overall Number of Participants Analyzed 3932
Measure Type: Number
Unit of Measure: Percentage of patients
1.04
3.Primary Outcome
Title Change From Baseline in SBP (Systolic Blood Pressure) at Week 2
Hide Description Effect on decrease in systolic blood pressure
Time Frame Baseline and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,616 patients for the efficacy assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
Overall Number of Participants Analyzed 3614
Mean (Standard Deviation)
Unit of Measure: mmHg
-29  (16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test for paired observations
Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2
Hide Description Effect on decrease in diastolic blood pressure
Time Frame Baseline and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,616 patients for the efficacy assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
Overall Number of Participants Analyzed 3614
Mean (Standard Deviation)
Unit of Measure: mmHg
-15  (11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test for paired observations
Comments [Not Specified]
5.Primary Outcome
Title Effective Rate
Hide Description

Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows:

Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved)

Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed)

Time Frame Baseline and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,616 patients for the efficacy assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
Overall Number of Participants Analyzed 3616
Measure Type: Number
Unit of Measure: Percentage of patients
99
6.Secondary Outcome
Title Gender Factors Affecting the Safety Profile
Hide Description Occurrence status of adverse events by Gender category of patients
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Gender not recorded for 15 patients
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
Overall Number of Participants Analyzed 3917
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
Male
1.24
(0.79 to 1.85)
Female
0.88
(0.52 to 1.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2669
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Age Factors Affecting the Safety Profile
Hide Description Occurrence status of adverse events by Age category of patients
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
Overall Number of Participants Analyzed 3917
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
20 ≤ age < 30
0 [1] 
(NA to NA)
30 ≤ age < 40
1.32
(0.16 to 4.70)
40 ≤ age < 50
1.20
(0.52 to 2.34)
50 ≤ age < 60
1.13
(0.58 to 1.96)
60 ≤ age < 70
0.88
(0.42 to 1.62)
≥ 70
1.04
(0.48 to 1.96)
[1]
Percentage of Patients with this category is 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9674
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Proportion of Geriatric Population Factor Affecting the Safety Profile
Hide Description Occurrence status of adverse events by Proportion of geriatric population of patients
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
Overall Number of Participants Analyzed 3917
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
< 65
1.03
(0.68 to 1.51)
>= 65
1.07
(0.60 to 1.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9207
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Treatment Type Factors Affecting the Safety Profile
Hide Description Occurrence status of adverse events by Treatment type of patients
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Treatment type not recorded for 294 patients
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
Overall Number of Participants Analyzed 3638
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
In-patient
0 [1] 
(NA to NA)
Out-patient
1.10
(0.78 to 1.51)
In-patient and outpatient alternatively
1.40
(0.17 to 4.96)
[1]
Percentage of Patients with this category is 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8249
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Medical History Factors Affecting the Safety Profile
Hide Description Occurrence status of adverse events by medical history of patients
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
Overall Number of Participants Analyzed 3932
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
With Medical history
1.97
(1.24 to 2.96)
Without Medical history
0.68
(0.41 to 1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
1.121 to 4.151
Estimation Comments The estimation of Odds Ratio and 95% Confidence Interval based on the logistic regression analysis
11.Secondary Outcome
Title Concomitant Disease Factors Affecting the Safety Profile
Hide Description Occurrence status of adverse events by Concomitant disease of patients
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901. The number of patients for safety assessment: 3932
Overall Number of Participants Analyzed 3932
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients
With Concomitant disease
2.30
(1.49 to 3.38)
Without Concomitant disease
0.56
(0.32 to 0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
1.642 to 6.776
Estimation Comments The Estimation of Odds Ratio and 95% Confidence Interval based the logistic regression analysis
12.Secondary Outcome
Title Medical History Factors Affecting the Efficacy Profile
Hide Description Efficacy rate by medical characteristic of patients
Time Frame Baseline and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,616 patients for the efficacy assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
Overall Number of Participants Analyzed 3616
Measure Type: Number
Unit of Measure: Percentage of patients
With Medical history 98.1
Without Medical history 99.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
13.Secondary Outcome
Title Previous Medication Factors Affecting the Efficacy Profile
Hide Description Efficacy rate by medical characteristic of patients
Time Frame Baseline and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,616 patients for the efficacy assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
Overall Number of Participants Analyzed 3616
Measure Type: Number
Unit of Measure: Percentage of patients
With Previous medication 98.3
Without Previous medication 99.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
14.Secondary Outcome
Title Baseline Severity of Hypertension Factors Affecting the Efficacy Profile
Hide Description

Efficacy rate by medical characteristic of patients

Stage 1 (SBP 140~159 mmHg or DBP 90~99 mmHg) Stage 2 (SBP 160~179 mmHg or DBP 100~109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)

Time Frame Baseline and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,616 patients for the efficacy assessment
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
Overall Number of Participants Analyzed 3616
Measure Type: Number
Unit of Measure: Percentage of patients
Stage 1 98.3
Stage 2 99.2
Stage 3 98.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0393
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
15.Secondary Outcome
Title Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile
Hide Description

Efficacy rate by medical characteristic of patients

40/12.5mg < daily dose < 80/12.5mg - Because some physicians changed the daily dose based on patient’s BP control result, this range exists

Time Frame Baseline and End of Study
Hide Outcome Measure Data
Hide Analysis Population Description
Out of 6,901 patients, 3,616 patients for the efficacy assessment and Daily dose not recorded for 26 patients
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description:
In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3932/ The number of patients for efficacy assessment: 3616.
Overall Number of Participants Analyzed 3590
Measure Type: Number
Unit of Measure: Percentage of patients
40/12.5mg 98.8
40/12.5mg < daily dose < 80/12.5mg 95.8
80/12.5mg 99.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypertensive Patients With Micardis Plus for the First Time
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0245
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame Over a period of 6 years
Adverse Event Reporting Description The number of patients for safety assessment is 3932.
 
Arm/Group Title Hypertensive Patients With Micardis Plus for the First Time
Hide Arm/Group Description In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616.
All-Cause Mortality
Hypertensive Patients With Micardis Plus for the First Time
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Hypertensive Patients With Micardis Plus for the First Time
Affected / at Risk (%)
Total   1/3932 (0.03%) 
Vascular disorders   
Stroke  1  1/3932 (0.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, WHO-ART 2006
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hypertensive Patients With Micardis Plus for the First Time
Affected / at Risk (%)
Total   0/3932 (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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00659607     History of Changes
Other Study ID Numbers: 502.475
First Submitted: April 10, 2008
First Posted: April 16, 2008
Results First Submitted: July 29, 2009
Results First Posted: October 22, 2009
Last Update Posted: June 6, 2014