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Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

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ClinicalTrials.gov Identifier: NCT01050062
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : January 30, 2013
Last Update Posted : May 1, 2014
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Hypertension
Interventions Drug: Telmisartan 80mg
Drug: Telmisartan 40mg
Drug: Hydrochlorothiazide 12.5mg
Enrollment 1452
Recruitment Details A total of 1452 patients were enrolled. Of these patients, the CRFs of 9 patients were uncollected by reason of institution, and the 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey.
Pre-assignment Details  
Arm/Group Title Combination Tablet AP Combination Tablet BP
Hide Arm/Group Description Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
Period Title: Overall Study
Started 1070 355
Completed 799 243
Not Completed 271 112
Reason Not Completed
Adverse Event             75             22
Lost to Follow-up             83             35
Lack of Efficacy             22             35
Physician Decision             74             9
Others             17             11
Arm/Group Title Combination Tablet AP Combination Tablet BP Total
Hide Arm/Group Description Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg Total of all reporting groups
Overall Number of Baseline Participants 1070 355 1425
Hide Baseline Analysis Population Description
The 18 patients which had no information including safety due to no visit after enrolled, were excluded from the safety analysis, 1,425 patients were included in the safety set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1070 participants 355 participants 1425 participants
68.6  (12.0) 69.8  (12.5) 68.9  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1070 participants 355 participants 1425 participants
Female
570
  53.3%
186
  52.4%
756
  53.1%
Male
500
  46.7%
169
  47.6%
669
  46.9%
1.Primary Outcome
Title Incidence of Adverse Events (AEs)
Hide Description The number of patient with any AEs, patients with drug-related AEs
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The all treated patients, 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey
Arm/Group Title Combination Tablet AP Combination Tablet BP Total
Hide Arm/Group Description:
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
Overall Number of Participants Analyzed 1070 355 1425
Measure Type: Number
Unit of Measure: Patients
patient with any AEs 221 72 293
patients with drug-related AEs 154 46 200
2.Secondary Outcome
Title Systolic Blood Pressure (SBP)
Hide Description SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.
Time Frame Week 0 and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
Arm/Group Title Combination Tablet AP Combination Tablet BP Total
Hide Arm/Group Description:
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
Overall Number of Participants Analyzed 1060 352 1412
Mean (Standard Deviation)
Unit of Measure: mmHg
Week 0 152.9  (18.3) 155.4  (18.7) 153.5  (18.4)
Week 52 132.2  (15.1) 134.7  (15.5) 132.8  (15.2)
Change from Week 0 to Week 52 -20.7  (18.8) -20.7  (21.5) -20.7  (19.5)
3.Secondary Outcome
Title Diastolic Blood Pressure (DBP)
Hide Description DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.
Time Frame Week 0 and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
Arm/Group Title Combination Tablet AP Combination Tablet BP Total
Hide Arm/Group Description:
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
Overall Number of Participants Analyzed 1060 352 1412
Mean (Standard Deviation)
Unit of Measure: mmHg
Week 0 84.7  (13.0) 84.6  (12.8) 84.7  (13.0)
Week 52 75.2  (10.9) 75.5  (11.2) 75.3  (11.0)
Change from Week 0 to Week 52 -9.5  (11.6) -9.1  (13.9) -9.4  (12.2)
4.Secondary Outcome
Title Target Blood Pressure Achievement Rate
Hide Description The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for >= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
Arm/Group Title Combination Tablet AP Combination Tablet BP Total
Hide Arm/Group Description:
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
Overall Number of Participants Analyzed 1060 352 1412
Measure Type: Number
Unit of Measure: Percentage of patients
52.9 43.2 50.5
5.Secondary Outcome
Title Blood Pressure Normalised Rate
Hide Description The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009
Time Frame Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The 13 patients which no efficacy information, were excluding from safety set, 1412 patients were included in efficacy set.
Arm/Group Title Combination Tablet AP Combination Tablet BP Total
Hide Arm/Group Description:
Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
Overall Number of Participants Analyzed 1060 352 1412
Measure Type: Number
Unit of Measure: percentage of participants
70.7 61.1 68.3
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combination Tablet Ap Combination Tablet BP Total
Hide Arm/Group Description Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
All-Cause Mortality
Combination Tablet Ap Combination Tablet BP Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Combination Tablet Ap Combination Tablet BP Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/1070 (2.34%)   12/355 (3.38%)   37/1425 (2.60%) 
Cardiac disorders       
Acute myocardial infarction  1  0/1070 (0.00%)  1/355 (0.28%)  1/1425 (0.07%) 
Angina pectoris  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Angina unstable  1  0/1070 (0.00%)  1/355 (0.28%)  1/1425 (0.07%) 
Cardiac failure congestive  1  0/1070 (0.00%)  1/355 (0.28%)  1/1425 (0.07%) 
Sick sinus syndrome  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Gastrointestinal disorders       
Autoimmune pancreatitis  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
General disorders       
Death  1  0/1070 (0.00%)  1/355 (0.28%)  1/1425 (0.07%) 
Hepatobiliary disorders       
Cholangitis acute  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Cholecystitis acute  1  2/1070 (0.19%)  0/355 (0.00%)  2/1425 (0.14%) 
Cholelithiasis  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Hepatic failure  1  0/1070 (0.00%)  1/355 (0.28%)  1/1425 (0.07%) 
Infections and infestations       
Gastroenteritis  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Arthritis bacterial  1  0/1070 (0.00%)  1/355 (0.28%)  1/1425 (0.07%) 
Pneumonia bacterial  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Pneumocystis jiroveci pneumonia  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Diabetic ketoacidosis  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Hyperkalaemia  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Hypoglycaemia  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Hypokalaemia  1  2/1070 (0.19%)  1/355 (0.28%)  3/1425 (0.21%) 
Hyponatraemia  1  2/1070 (0.19%)  1/355 (0.28%)  3/1425 (0.21%) 
Hypophagia  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Musculoskeletal and connective tissue disorders       
Mixed connective tissue disease  1  0/1070 (0.00%)  1/355 (0.28%)  1/1425 (0.07%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatic neoplasm malignant  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Metastases to bone  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Nervous system disorders       
Cerebral infarction  1  3/1070 (0.28%)  1/355 (0.28%)  4/1425 (0.28%) 
Cerebrovascular disorder  1  0/1070 (0.00%)  1/355 (0.28%)  1/1425 (0.07%) 
Loss of consciousness  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Transient ischaemic attack  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Psychiatric disorders       
Completed suicide  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Renal and urinary disorders       
Calculus urinary  1  0/1070 (0.00%)  1/355 (0.28%)  1/1425 (0.07%) 
Renal failure chronic  1  1/1070 (0.09%)  1/355 (0.28%)  2/1425 (0.14%) 
Renal impairment  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonia aspiration  1  1/1070 (0.09%)  0/355 (0.00%)  1/1425 (0.07%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Tablet Ap Combination Tablet BP Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1070 (0.00%)   0/355 (0.00%)   0/1425 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01050062     History of Changes
Other Study ID Numbers: 502.542
First Submitted: December 24, 2009
First Posted: January 15, 2010
Results First Submitted: December 18, 2012
Results First Posted: January 30, 2013
Last Update Posted: May 1, 2014