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Trial record 16 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Compare Efficacy and Safety of Telmisartan/Hydrochlorothiazide With Telmisartan/Hydrochlorothiazide Plus Amlodipine

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ClinicalTrials.gov Identifier: NCT01911780
Recruitment Status : Completed
First Posted : July 30, 2013
Results First Posted : March 28, 2016
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: placebo
Drug: telmisartan + HCTZ
Drug: amlodipine
Enrollment 132
Recruitment Details Of the 239 enrolled patients, 205 patients were entered in the run-in period and 132 were randomized. The remaining 107 patients were withdrawn from the trial before the randomization.
Pre-assignment Details An eight-week randomised, double-blind study with active-control and parallel-group comparison in Japanese patients plus 52 week extension period.
Arm/Group Title Telmisartan + HCTZ + Amlodipine Telmisartan + HCTZ + Placebo
Hide Arm/Group Description telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Period Title: Double-blind Period (8 Weeks)
Started 68 64
Completed 65 61
Not Completed 3 3
Reason Not Completed
Adverse Event             1             2
Consent withdrawn not due to AEs             1             1
Personal reason             1             0
Period Title: Extension Period (52 Weeks)
Started 65 61
Completed 61 58
Not Completed 4 3
Reason Not Completed
Adverse Event             3             0
Consent withdrawn not due to AEs             0             2
Personal reason             1             1
Arm/Group Title Telmisartan + HCTZ + Amlodipine Telmisartan + HCTZ + Placebo Total
Hide Arm/Group Description telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) Total of all reporting groups
Overall Number of Baseline Participants 68 64 132
Hide Baseline Analysis Population Description
Treated set (TS) was defined as a collection of patients i) randomised to the double-blind period; ii) taking at least 1 dose of either T80/A5/H12.5 mg or T80/H12.5 mg during the double-blind period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 64 participants 132 participants
56.1  (10.2) 54.4  (7.9) 55.2  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 64 participants 132 participants
Female
13
  19.1%
15
  23.4%
28
  21.2%
Male
55
  80.9%
49
  76.6%
104
  78.8%
1.Primary Outcome
Title Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
Hide Description Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period
Arm/Group Title Telmisartan + HCTZ + Amlodipine Telmisartan + HCTZ + Placebo
Hide Arm/Group Description:
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Overall Number of Participants Analyzed 67 64
Mean (Standard Error)
Unit of Measure: mmHg
-8.8  (0.8) -1.3  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan + HCTZ + Amlodipine, Telmisartan + HCTZ + Placebo
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 LOCF-ANCOVA
Comments Last observation carried forward (LOCF) was used as the imputation method
Method of Estimation Estimation Parameter Adjusted mean, comparison
Estimated Value -7.5
Confidence Interval (2-Sided) 95%
-9.7 to -5.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.1
Estimation Comments Model includes baseline DBP as a linear covariate, and treatment and center as fixed effects.
2.Secondary Outcome
Title Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.
Hide Description Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan + HCTZ + Amlodipine Telmisartan + HCTZ + Placebo
Hide Arm/Group Description:
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Overall Number of Participants Analyzed 67 64
Mean (Standard Error)
Unit of Measure: mmHg
-10.6  (1.4) -2.1  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan + HCTZ + Amlodipine, Telmisartan + HCTZ + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Additional information, the p-value is not adjusted for multiplicity.
Method LOCF-ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted mean, comparison
Estimated Value -8.6
Confidence Interval (2-Sided) 95%
-12.7 to -4.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.1
Estimation Comments Model includes baseline SBP as a linear covariate, and treatment and center as fixed effects.
3.Secondary Outcome
Title The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.
Hide Description The percentage of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.
Time Frame Double-blind and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan + HCTZ + Amlodipine Telmisartan + HCTZ + Placebo
Hide Arm/Group Description:
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Overall Number of Participants Analyzed 67 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Participants
44.8
(32.6 to 57.4)
21.9
(12.5 to 34.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan + HCTZ + Amlodipine, Telmisartan + HCTZ + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments Additional information, the p-value is not adjusted for multiplicity.
Method Regression, Logistic
Comments Non-completers considered failures (NCF) was used as the imputation method.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
1.4 to 7.1
Estimation Comments Exact 95 % confidence interval by Clopper and Pearson. Logistic regression includes treatment and center.
4.Secondary Outcome
Title The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.
Hide Description

The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.

The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.

Time Frame Reference baseline (week 0) and week 60 (end of extension period)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Telmisartan + HCTZ + Amlodipine Telmisartan + HCTZ + Placebo
Hide Arm/Group Description:
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Overall Number of Participants Analyzed 65 61
Measure Type: Number
Unit of Measure: Participants
Yes 41 33
No 24 28
5.Secondary Outcome
Title Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.
Hide Description

Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.

The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.

Time Frame Reference baseline (week 0) and week 60 (end of extension period)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS in the extension period (FASEX OC) was defined as a collection of patients i) included in the FAS; ii) taking at least 1 dose of T80/A5/H12.5 mg in the extension period; and iii) taking measurements of seated DBP at reference baseline and at 1 or more time points in the extension period.
Arm/Group Title Telmisartan + HCTZ + Amlodipine + Ext Telmisartan + HCTZ + Placebo + Ext
Hide Arm/Group Description:
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Overall Number of Participants Analyzed 61 58
Mean (Standard Error)
Unit of Measure: mmHg
Mean -11.4  (1.0) -10.0  (1.0)
Adjusted mean -10.9  (1.0) -10.5  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan + HCTZ + Amlodipine + Ext, Telmisartan + HCTZ + Placebo + Ext
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method mixed-effects model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-3.1 to 2.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.4
Estimation Comments As a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.
6.Secondary Outcome
Title Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.
Hide Description

Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.

The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values’. The 'adjusted mean' is shown as 'mean'.

Time Frame Reference baseline (week 0) and week 60 (end of extension period)
Hide Outcome Measure Data
Hide Analysis Population Description
FASEX (OC)
Arm/Group Title Telmisartan + HCTZ + Amlodipine + Ext Telmisartan + HCTZ + Placebo + Ext
Hide Arm/Group Description:
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Overall Number of Participants Analyzed 61 58
Mean (Standard Error)
Unit of Measure: mmHg
Mean -14.8  (1.6) -14.3  (1.6)
Adjusted mean -13.6  (1.3) -15.9  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan + HCTZ + Amlodipine + Ext, Telmisartan + HCTZ + Placebo + Ext
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method mixed-effects model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-1.5 to 6.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.9
Estimation Comments Model includes baseline SBP as a linear covariate, and treatment and visit, treatment by visit interaction and baseline value by visit interaction as fixed effects.
Time Frame Up to 60 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telmisartan + HCTZ + Amlodipine - Double Blind Period Telmisartan + HCTZ + Placebo - Double Blind Period Telmisartan + HCTZ + Amlodipine - Extension Period Telmisartan + HCTZ + Placebo - Extension Period
Hide Arm/Group Description Telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks (double blind period) Telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks (double-blind period) Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks in the double blind period. Adverse events which occurred in extension period were collected. Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks in the double-blind period. Adverse events which occurred in extension period were collected.
All-Cause Mortality
Telmisartan + HCTZ + Amlodipine - Double Blind Period Telmisartan + HCTZ + Placebo - Double Blind Period Telmisartan + HCTZ + Amlodipine - Extension Period Telmisartan + HCTZ + Placebo - Extension Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telmisartan + HCTZ + Amlodipine - Double Blind Period Telmisartan + HCTZ + Placebo - Double Blind Period Telmisartan + HCTZ + Amlodipine - Extension Period Telmisartan + HCTZ + Placebo - Extension Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/64 (0.00%)   2/65 (3.08%)   2/61 (3.28%) 
Gastrointestinal disorders         
Large intestine polyp  1  0/68 (0.00%)  0/64 (0.00%)  0/65 (0.00%)  1/61 (1.64%) 
Injury, poisoning and procedural complications         
Rib fracture  1  0/68 (0.00%)  0/64 (0.00%)  1/65 (1.54%)  0/61 (0.00%) 
Spinal fracture  1  0/68 (0.00%)  0/64 (0.00%)  1/65 (1.54%)  0/61 (0.00%) 
Nervous system disorders         
Lacunar infarction  1  0/68 (0.00%)  0/64 (0.00%)  0/65 (0.00%)  1/61 (1.64%) 
Respiratory, thoracic and mediastinal disorders         
Haemothorax  1  0/68 (0.00%)  0/64 (0.00%)  1/65 (1.54%)  0/61 (0.00%) 
Pulmonary embolism  1  0/68 (0.00%)  0/64 (0.00%)  1/65 (1.54%)  0/61 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  0/68 (0.00%)  0/64 (0.00%)  1/65 (1.54%)  0/61 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telmisartan + HCTZ + Amlodipine - Double Blind Period Telmisartan + HCTZ + Placebo - Double Blind Period Telmisartan + HCTZ + Amlodipine - Extension Period Telmisartan + HCTZ + Placebo - Extension Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/68 (10.29%)   6/64 (9.38%)   26/65 (40.00%)   16/61 (26.23%) 
Infections and infestations         
Nasopharyngitis  1  6/68 (8.82%)  6/64 (9.38%)  23/65 (35.38%)  16/61 (26.23%) 
Respiratory, thoracic and mediastinal disorders         
Upper respiratory tract inflammation  1  2/68 (2.94%)  1/64 (1.56%)  4/65 (6.15%)  1/61 (1.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01911780     History of Changes
Other Study ID Numbers: 1348.2
First Submitted: July 26, 2013
First Posted: July 30, 2013
Results First Submitted: January 22, 2016
Results First Posted: March 28, 2016
Last Update Posted: March 28, 2016