Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

26-week Open Study of telmisartan40mg+amlodipine10mg or telmisartan80mg+amlodipine10 mg in 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: NCT00624052
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : March 25, 2010
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: fixed-dose combination of telmisartan 40mg+amlodipine 10mg
Drug: fixed-dose combination of telmisartan 80mg+amlodipine10mg
Enrollment 838
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description Patients who were randomised to telmisartan 40mg and amlodipine 10mg and were on this dose at their last study visit Patients who were randomised to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit Patients who were randomised to telmisartan 40mg and amlodipine 10mg but were titrated to telmisartan 80mg and amlodipine 10mg and were on this dose at their last study visit Patients who were on either telmisartan 40 mg or 80mg and amlodipine 10mg plus another antihypertensive medication at their last study visit
Period Title: Overall Study
Started 219 436 91 92
Completed 204 422 88 88
Not Completed 15 14 3 4
Reason Not Completed
Adverse Event             7             6             0             3
Lack of Efficacy             1             1             0             0
Lost to Follow-up             2             3             1             0
Non compliant with the protocol             2             1             1             1
Consent withdrawn             3             1             1             0
Changed job/ran out if meds             0             2             0             0
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 219 436 91 92 838
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 219 participants 436 participants 91 participants 92 participants 838 participants
56.2  (9.9) 57.3  (9.4) 55.2  (9.7) 53.3  (10.3) 56.4  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants 436 participants 91 participants 92 participants 838 participants
Female
93
  42.5%
206
  47.2%
31
  34.1%
37
  40.2%
367
  43.8%
Male
126
  57.5%
230
  52.8%
60
  65.9%
55
  59.8%
471
  56.2%
1.Primary Outcome
Title Trough Seated Diastolic Blood Pressure (DBP) Control
Hide Description The number of patients who reached the target DBP of <90mmHg
Time Frame End of study (34 weeks or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 216 436 91 92
Measure Type: Number
Unit of Measure: patients
Yes (DBP<90 mmHg) 201 402 72 70
No (DBP>=90 mmHg) 15 34 19 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telmisartan 40mg and Amlodipine 10mg, Randomised Telmisartan 80mg and Amlodipine 10mg
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval 95%
0.47 to 1.66
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Telmisartan 40mg and Amlodipine 10mg, Titrated Telmisartan 80mg and Amlodipine 10mg
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.28
Confidence Interval 95%
0.14 to 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Telmisartan 40mg and Amlodipine 10mg, Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.24
Confidence Interval 95%
0.12 to 0.48
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Randomised Telmisartan 80mg and Amlodipine 10mg, Titrated Telmisartan 80mg and Amlodipine 10mg
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.32
Confidence Interval 95%
0.17 to 0.59
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Randomised Telmisartan 80mg and Amlodipine 10mg, Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.27
Confidence Interval 95%
0.15 to 0.49
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Titrated Telmisartan 80mg and Amlodipine 10mg, Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval 95%
0.42 to 1.68
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Trough Seated Systolic Blood Pressure (SBP) Control
Hide Description The number of patients who reached the target SBP of >=140mmHg
Time Frame End of study (34 weeks or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 216 436 91 92
Measure Type: Number
Unit of Measure: patients
Yes (SBP<140 mmHg) 179 366 70 51
No (SBP>=140 mmHg) 37 70 21 41
3.Secondary Outcome
Title Change From Baseline to End of Study in Trough Seated Diastolic Blood Pressure
Hide Description Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.6
Time Frame Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 214 434 87 91
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-13.41  (0.44) -13.36  (0.31) -11.52  (0.69) -10.64  (0.67)
4.Secondary Outcome
Title Change in DBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Hide Description The difference between the last available troughs represents the additional reduction in DBP in this study
Time Frame Last available trough in NCT00553267 to end of study (34 weeks or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 213 430 91 92
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-4.36  (0.48) -4.97  (0.34) -5.51  (0.74) -5.43  (0.73)
5.Secondary Outcome
Title Change From Baseline to End of Study in Trough Seated Systolic Blood Pressure
Hide Description Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.6
Time Frame Baseline is defined as visit 3 of study NCT00553267 and end of study as 34 weeks or last value on treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT00553267) and at least one on treatment BP measurement 20-30 hours post dose
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 214 434 87 91
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-14.76  (0.72) -15.93  (0.5) -14.85  (1.12) -12.44  (1.1)
6.Secondary Outcome
Title Change in SBP From Last Available Trough in NCT00553267 to Last Available Trough in NCT00624052
Hide Description The difference between the last available troughs represents the additional reduction in SBP in this study
Time Frame Last available trough in NCT00624052 to end of study (34 weeks or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who took at least one dose of study medication, have a trough end of study measurement from NCT00553267 and at least one on treatment BP measurement 20-30 hours post dose
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 213 430 91 92
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-4.73  (0.73) -6.02  (0.51) -6.55  (1.11) -5.61  (1.1)
7.Secondary Outcome
Title Trough Seated DBP Response
Hide Description The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg
Time Frame End of study (34 weeks or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 214 434 87 91
Measure Type: Number
Unit of Measure: patients
Yes (Responder) 201 405 71 73
No (Non-responder) 13 29 16 18
8.Secondary Outcome
Title Trough Seated SBP Response
Hide Description The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg
Time Frame End of study (34 weeks or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 NCT 00553267) and at least one on treatment BP measurement 20-30 hours post dose
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 214 434 87 91
Measure Type: Number
Unit of Measure: patients
Yes (Responder) 190 401 75 69
No (Non-responder) 24 33 12 22
9.Secondary Outcome
Title Trough BP Normality Classes
Hide Description The number of patients who reach predefined BP categories
Time Frame End of study (34 weeks or last value on treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Randomised Telmisartan 80mg and Amlodipine 10mg Titrated Telmisartan 80mg and Amlodipine 10mg Telmisartan 40mg or 80mg and Amlodipine 10mg + add-on
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 213 430 91 92
Measure Type: Number
Unit of Measure: patients
Optimal (SBP<120 and DBP<80 mmHg) 12 20 5 3
Normal (SBP<130 and DBP<85 mmHg and not optimal) 70 146 14 13
High-normal (SBP<140 DBP<90 mmHg and not normal) 94 189 46 29
Stage 1 hypertension (SBP<160 and DBP<100 mmHg 32 76 23 43
Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg) 8 5 3 4
10.Secondary Outcome
Title Time to First Additional Antihypertensive
Hide Description Time from first intake of medication to first intake of an antihypertensive other than the study drug
Time Frame up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The total of the number of patients in the BP normality classes. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 121
Mean (Standard Deviation)
Unit of Measure: Days
91.9  (45.2)
11.Secondary Outcome
Title Number of Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Hide Description The number of patients with DBP control (DBP>=90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment
Time Frame up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment
Arm/Group Title Pre-antihypertensive: Yes (DBP<90 mmHg) Pre-antihypertensive: No (DBP>=90 mmHg) Pre-antihypertensive: Total
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 90 121
Measure Type: Number
Unit of Measure: patients
Post-antihypertensive: Yes (DBP<90 mmHg) 27 67 94
Post-antihypertensive: No (DBP>=90 mmHg) 4 23 27
Post-antihypertensive: Total 31 90 121
12.Secondary Outcome
Title Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Hide Description Difference in trough DBP from last visit before add-on therapy and last visit during NCT00624052
Time Frame up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total for the full analysis set. Decision to treat with additional antihypertensive was at investigator discretion. Some patients may have been deemed to be at higher cardiovascular risk therefore requiring additional antihypertensive treatment
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 121
Mean (Standard Deviation)
Unit of Measure: mmHg
-6.79  (7.39)
13.Secondary Outcome
Title Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Hide Description Difference in trough SBP from last visit before add-on therapy and last visit during NCT00624052
Time Frame up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Total for the full analysis set
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 121
Mean (Standard Deviation)
Unit of Measure: mmHg
-7.79  (12.37)
14.Secondary Outcome
Title Trough DBP Control Pre- and Post- Uptitration
Hide Description The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to telmisartan 80mg and amlodipine 10mg compared to first trough DBP taken after uptitration. Uptitration could be based DBP>90 or investigator opinion.
Time Frame up to 34 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
91 is the number of patients titrated to telmisartan 80mg. To get 582 you need to consider the randomised to telmisartan 80 mg patients and those with additional antihypertensive that were on telmisartan 80mg.
Arm/Group Title Pre-titration: Yes (DBP<90 mmHg) Pre-titration: No (DBP>=90 mmHg) Pre-titration: Total
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 324 258 582
Measure Type: Number
Unit of Measure: patients
Post-titration: Yes (DBP<90 mmHg) 306 168 474
Post-titration: No (DBP>=90 mmHg) 18 90 108
Post-titration: Total 324 258 582
Time Frame From day of first dose through to the day after last dose
Adverse Event Reporting Description Safety data was analysed based upon actual dose of telmisartan and amlodipine the patient was on at the onset of AE regardless of additional antihypertensive
 
Arm/Group Title Telmisartan 40mg and Amlodipine 10mg Telmisartan 80mg and Amlodipine 10mg
Hide Arm/Group Description The 838 participants in the telmisartan 40mg/amlodipine 10mg group includes all participants The 611 participants in the telmisartan 80mg/amlodipine 10mg (T80/A10) group include 436 patients in the randomised T80/A10 group + 91 patients in the uptitrated T80/A10 group + XX patients in the T80/A10 + add-on group
All-Cause Mortality
Telmisartan 40mg and Amlodipine 10mg Telmisartan 80mg and Amlodipine 10mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telmisartan 40mg and Amlodipine 10mg Telmisartan 80mg and Amlodipine 10mg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/838 (0.48%)   13/611 (2.13%) 
Cardiac disorders     
Atrial fibrillation  1  1/838 (0.12%)  1/611 (0.16%) 
Cardiac failure chronic  1  0/838 (0.00%)  1/611 (0.16%) 
Myocardial ischaemia  1  0/838 (0.00%)  1/611 (0.16%) 
General disorders     
Chest pain  1  0/838 (0.00%)  1/611 (0.16%) 
Hepatobiliary disorders     
Cholecystitis  1  0/838 (0.00%)  1/611 (0.16%) 
Infections and infestations     
Pulmonary tuberculosis  1  0/838 (0.00%)  1/611 (0.16%) 
Stent related infection  1  0/838 (0.00%)  1/611 (0.16%) 
Vestibular neuronitis  1  1/838 (0.12%)  0/611 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/838 (0.00%)  1/611 (0.16%) 
Fall  1  0/838 (0.00%)  1/611 (0.16%) 
Postoperative fever  1  1/838 (0.12%)  0/611 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/838 (0.00%)  1/611 (0.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder neoplasm  1  0/838 (0.00%)  1/611 (0.16%) 
Fibrosarcoma  1  0/838 (0.00%)  1/611 (0.16%) 
Prostate cancer  1  1/838 (0.12%)  0/611 (0.00%) 
Prostatic adenoma  1  0/838 (0.00%)  1/611 (0.16%) 
Renal and urinary disorders     
Calculus ureteric  1  0/838 (0.00%)  1/611 (0.16%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/838 (0.12%)  0/611 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/838 (0.00%)  1/611 (0.16%) 
Haemoptysis  1  0/838 (0.00%)  1/611 (0.16%) 
Pulmonary embolism  1  1/838 (0.12%)  1/611 (0.16%) 
Skin and subcutaneous tissue disorders     
Parasoriasis  1  0/838 (0.00%)  1/611 (0.16%) 
Vascular disorders     
Aortic dissection  1  0/838 (0.00%)  1/611 (0.16%) 
Hypertensive crisis  1  0/838 (0.00%)  2/611 (0.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telmisartan 40mg and Amlodipine 10mg Telmisartan 80mg and Amlodipine 10mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/838 (0.00%)   0/611 (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: NCT00624052     History of Changes
Other Study ID Numbers: 1235.8
First Submitted: February 5, 2008
First Posted: February 26, 2008
Results First Submitted: December 28, 2009
Results First Posted: March 25, 2010
Last Update Posted: May 20, 2014