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Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

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ClinicalTrials.gov Identifier: NCT00926289
Recruitment Status : Completed
First Posted : June 23, 2009
Results First Posted : May 24, 2011
Last Update Posted : June 27, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Telmisartan
Drug: Hydrochlorothiazide
Enrollment 894

Recruitment Details  
Pre-assignment Details 894 patients were entered (randomised) into the study; however, of these, 6 were not treated. Therefore 888 patients actually entered into treatment.
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg
Hide Arm/Group Description Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Period Title: Overall Study
Started 294 [1] 594 [1]
Completed 269 558
Not Completed 25 36
Reason Not Completed
Adverse Event             9             11
Protocol Violation             8             12
Lost to Follow-up             3             6
Withdrawal by Subject             4             4
not specified             1             3
[1]
Number of treated patients
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg Total
Hide Arm/Group Description Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 294 594 888
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 294 participants 594 participants 888 participants
57.6  (11.9) 56.8  (11.3) 57.0  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 294 participants 594 participants 888 participants
Female
125
  42.5%
285
  48.0%
410
  46.2%
Male
169
  57.5%
309
  52.0%
478
  53.8%
1.Primary Outcome
Title Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7
Hide Description The SBP value at baseline was subtracted from the SBP value at Week 7.
Time Frame Baseline and Week 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 263 541
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-28.5  (0.88) -37.0  (0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.5
Confidence Interval 95%
-10.6 to -6.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean Seated Trough Cuff SBP to Week 5
Hide Description The SBP value at baseline was subtracted from the SBP value at Week 5.
Time Frame Baseline and Week 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 270 550
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-28.6  (0.86) -35.8  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.3
Confidence Interval 95%
-9.3 to -5.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean Seated Trough Cuff SBP to Week 3
Hide Description The SBP value at baseline was subtracted from the SBP value at Week 3.
Time Frame Baseline and Week 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 276 567
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-26.5  (0.87) -33.3  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.8
Confidence Interval 95%
-8.8 to -4.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7
Hide Description The DBP value at baseline was subtracted from the DBP value at Week 7.
Time Frame Baseline and Week 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 263 541
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-15.4  (0.55) -18.6  (0.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Fixed effects of treatment, week, treatment-by-week interaction, country with the continuous covariates of baseline and baseline-by-week interaction
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval 95%
-4.5 to -1.9
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7
Hide Description SBP control is defined as SBP < 140 mmHg.
Time Frame Week 7 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 285 573
Measure Type: Number
Unit of Measure: Participants
122 363
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline, treatment and country as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.36
Confidence Interval 95%
1.74 to 3.21
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5
Hide Description SBP control is defined as SBP < 140 mmHg
Time Frame Week 5 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 284 572
Measure Type: Number
Unit of Measure: Participants
119 355
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline, treatment and country as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.30
Confidence Interval 95%
1.70 to 3.12
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3
Hide Description SBP control is defined as SBP < 140 mmHg
Time Frame Week 3 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 276 567
Measure Type: Number
Unit of Measure: Participants
97 306
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline, treatment and country as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.19
Confidence Interval 95%
1.60 to 3.01
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7
Hide Description DBP control is defined as DBP<90 mmHg
Time Frame Week 7 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 285 573
Measure Type: Number
Unit of Measure: Participants
150 389
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline, treatment and country as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.00
Confidence Interval 95%
1.46 to 2.73
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5
Hide Description DBP control is defined as DBP<90 mmHg
Time Frame Week 5 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 284 572
Measure Type: Number
Unit of Measure: participants
150 391
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline, treatment and country as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.02
Confidence Interval 95%
1.48 to 2.76
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3
Hide Description DBP control is defined as DBP<90 mmHg
Time Frame Week 3 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 276 567
Measure Type: Number
Unit of Measure: Participants
131 343
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline and fixed effect country
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.74
Confidence Interval 95%
1.28 to 2.37
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Patients With Blood Pressure (BP) Control at Week 7
Hide Description BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline SBP
Time Frame Week 7 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 285 573
Measure Type: Number
Unit of Measure: Participants
99 318
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline (SBP), treatment and country as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.39
Confidence Interval 95%
1.76 to 3.26
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Patients With BP Control at Week 7
Hide Description BP control is defined as SBP<140 mmHg and DBP < 90 mmHg and is adjusted for baseline DBP
Time Frame Week 7 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 285 573
Measure Type: Number
Unit of Measure: Participants
99 318
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline (DBP), treatment and country as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.42
Confidence Interval 95%
1.78 to 3.29
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7
Hide Description SBP response is defined as SBP<140 mmHg or a reduction of >= 15 mmHg
Time Frame Week 7 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 285 573
Measure Type: Number
Unit of Measure: Participants
233 527
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline, treatment and country as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.62
Confidence Interval 95%
1.70 to 4.04
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Number of Participants With DBP Response at Week 7
Hide Description DBP response is defined as DBP<90 mmHg or a reduction of >= 10 mmHg
Time Frame Week 7 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 285 573
Measure Type: Number
Unit of Measure: Participants
202 483
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Adjustment for continuous covariate of baseline, treatment and country as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.23
Confidence Interval 95%
1.57 to 3.16
Estimation Comments [Not Specified]
15.Secondary Outcome
Title BP Categories at Week 7
Hide Description

BP categories comprise:

  • BP optimal (SBP <120 mmHg and DBP <80 mmHg)
  • BP normal (SBP <130 mmHg and DBP <85 mmHg but not ‘optimal’)
  • BP high normal (SBP <140 mmHg and DBP <90 mmHg but not ‘normal’)
  • Grade 1 hypertension (SBP <160 mmHg and DBP <100 mmHg but not ‘high normal’)
  • Grade 2 hypertension (SBP <180 mmHg and DBP <110 mmHg but not ‘Grade 1 hypertension’)
  • Grade 3 hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg)
Time Frame Week 7 timepoint
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients in the treated set who provide a baseline trough cuff BP measurement and at least one seated trough cuff BP measurement following titration to target therapy (T80+H25 or T80), taken on the same arm
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description:
Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
Overall Number of Participants Analyzed 285 573
Measure Type: Number
Unit of Measure: Participants
BP optimal 6 44
BP normal 36 136
BP high normal 57 138
Grade 1 hypertension 120 186
Grade 2 hypertension 44 58
Grade 3 hypertension 22 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40/80 mg, Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Comments T80+HCTZ25 versus T80 monotherapy
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Van Elteren test stratified for country
Comments [Not Specified]
Time Frame 7 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Hide Arm/Group Description Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
All-Cause Mortality
Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/294 (0.34%)   0/594 (0.00%) 
Nervous system disorders     
Epilepsy  1  1/294 (0.34%)  0/594 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Meddra 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telmisartan 40/80 mg Telmisartan 40/80 mg + HCTZ 12.5/25 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/294 (0.00%)   0/594 (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, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00926289     History of Changes
Other Study ID Numbers: 502.550
2008-007711-32 ( EudraCT Number: EudraCT )
First Submitted: June 22, 2009
First Posted: June 23, 2009
Results First Submitted: April 20, 2011
Results First Posted: May 24, 2011
Last Update Posted: June 27, 2014