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Trial record 20 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Pharmacokinetics of Different Formulations of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ) in Japanese Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT02183675
Recruitment Status : Completed
First Posted : July 8, 2014
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: Telmisartan/Amlodipine
Drug: Telmisartan/Amlodipine/HCTZ
Drug: Telmisartan/HCTZ
Enrollment 36
Recruitment Details An open-label, randomised, six-sequence crossover design. Each participant received three treatments each for 10 days. There was no washout period between treatments.
Pre-assignment Details  
Arm/Group Title T80-A5-H12.5 / T80-H12.5 / T80-A5 T80-H12.5 / T80-A5 / T80-A5-H12.5 T80-A5 / T80-A5-H12.5 / T80-H12.5 T80-A5 / T80-H12.5 / T80-A5-H12.5 T80-A5-H12.5 / T80-A5 / T80-H12.5 T80-H12.5 / T80-A5-H12.5 / T80-A5
Hide Arm/Group Description

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/Amlodipine 5mg/ hydrochlorothiazide (HCTZ) 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
  • Telmisartan 80mg/ HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Period Title: Treatment Period 1 (10 Days)
Started 6 6 6 6 6 6
Completed 6 6 6 6 6 6
Not Completed 0 0 0 0 0 0
Period Title: Treatment Period 2 (10 Days)
Started 6 6 6 6 6 6
Completed 6 6 6 6 6 4 [1]
Not Completed 0 0 0 0 0 2
Reason Not Completed
Adverse Event             0             0             0             0             0             2
[1]
Patients withdrew after completion of treatment period 2 but before beginning of treatment period 3
Period Title: Treatment Period 3 (10 Days)
Started 6 6 6 6 6 4
Completed 6 6 6 6 6 4
Not Completed 0 0 0 0 0 0
Arm/Group Title T80-A5-H12.5 / T80-H12.5 / T80-A5 T80-H12.5 / T80-A5 / T80-A5-H12.5 T80-A5 / T80-A5-H12.5 / T80-H12.5 T80-A5 / T80-H12.5 / T80-A5-H12.5 T80-A5-H12.5 / T80-A5 / T80-H12.5 T80-H12.5 / T80-A5-H12.5 / T80-A5 Total
Hide Arm/Group Description

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)

Participants received the three treatments, the treatments were administered orally in the following order:

  • Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)
  • Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)
Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 6 6 6 36
Hide Baseline Analysis Population Description
Treated set which included all subjects that were dispensed study drug and were documented to have taken at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 36 participants
29.0  (4.9) 27.3  (5.2) 27.0  (4.2) 25.8  (4.1) 29.5  (5.1) 29.3  (4.9) 28.0  (4.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 36 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
36
 100.0%
1.Primary Outcome
Title Maximum Measured Concentration (Cmax) at Steady State for Telmisartan
Hide Description Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau
Time Frame 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set which included all subjects in the treated set who had evaluable PK variable of test (T80/A5/H12.5 mg) and at least one of two references (T80/H12.5 mg and T80/A5 mg) for treatment periods 1, 2, and 3. Subjects who had a protocol deviation relevant to the evaluation of relative bioavailability were excluded.
Arm/Group Title T80-A5-H12.5 T80-A5 T80-H12.5
Hide Arm/Group Description:
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
Overall Number of Participants Analyzed 36 34 36
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
970
(69.3%)
857
(70.7%)
895
(75.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80-A5-H12.5, T80-H12.5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority limits: 80% − 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio (%)
Estimated Value 108.39
Confidence Interval (2-Sided) 90%
93.081 to 126.225
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.094
Estimation Comments Ratio calculated as T80-A5-H12.5 divided by T80-H12.5
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T80-A5-H12.5, T80-A5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority limits: 80% − 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio (%)
Estimated Value 114.86
Confidence Interval (2-Sided) 90%
98.216 to 134.326
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.097
Estimation Comments Ratio calculated as T80-A5-H12.5 divided by T80-A5
2.Primary Outcome
Title Area Under the Plasma Concentration Curve at Steady State for Telmisartan
Time Frame 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title T80-A5-H12.5 T80-A5 T80-H12.5
Hide Arm/Group Description:
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
Overall Number of Participants Analyzed 36 34 36
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
2510
(72.1%)
2570
(70.8%)
2580
(81.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80-A5-H12.5, T80-H12.5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority limits: 80% − 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio (%)
Estimated Value 97.53
Confidence Interval (2-Sided) 90%
90.43 to 105.19
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.05
Estimation Comments Ratio calculated as T80-A5-H12.5 divided by T80-H12.5
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection T80-A5-H12.5, T80-A5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority limits: 80% − 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio (%)
Estimated Value 102.04
Confidence Interval (2-Sided) 90%
96.94 to 107.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.03
Estimation Comments Ratio calculated as T80-A5-H12.5 divided by T80-A5
3.Primary Outcome
Title Maximum Measured Concentration (Cmax) at Steady State for Amlodipine
Hide Description Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau
Time Frame 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title T80-A5-H12.5 T80-A5
Hide Arm/Group Description:
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
Overall Number of Participants Analyzed 36 34
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
11.8
(21.8%)
11.3
(22.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80-A5-H12.5, T80-A5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority limits: 80% − 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio (%)
Estimated Value 103.95
Confidence Interval (2-Sided) 90%
101.023 to 106.964
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.017
Estimation Comments Ratio calculated as T80-A5-H12.5 divided by T80-A5
4.Primary Outcome
Title Area Under the Plasma Concentration Curve at Steady State for Amlodipine
Hide Description Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau
Time Frame 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title T80-A5-H12.5 T80-A5
Hide Arm/Group Description:
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
Overall Number of Participants Analyzed 36 34
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
230
(23.4%)
223
(21.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80-A5-H12.5, T80-A5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority limits: 80% − 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio (%)
Estimated Value 102.49
Confidence Interval (2-Sided) 90%
100.167 to 104.867
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.014
Estimation Comments Ratio calculated as T80-A5-H12.5 divided by T80-A5
5.Primary Outcome
Title Maximum Measured Concentration (Cmax) at Steady State for HCTZ
Hide Description Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau
Time Frame 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title T80-A5-H12.5 T80-H12.5
Hide Arm/Group Description:
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
Overall Number of Participants Analyzed 36 36
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
107
(28.5%)
102
(28.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80-A5-H12.5, T80-H12.5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority limits: 80% − 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio (%)
Estimated Value 105.35
Confidence Interval (2-Sided) 90%
99.230 to 111.847
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.036
Estimation Comments Ratio calculated as T80-A5-H12.5 divided by T80-H12.5
6.Primary Outcome
Title Area Under the Plasma Concentration Curve at Steady State for HCTZ
Hide Description Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau
Time Frame 15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title T80-A5-H12.5 T80-H12.5
Hide Arm/Group Description:
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
Overall Number of Participants Analyzed 36 36
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
584
(23.8%)
565
(23.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80-A5-H12.5, T80-H12.5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority limits: 80% − 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio (%)
Estimated Value 103.39
Confidence Interval (2-Sided) 90%
98.730 to 108.280
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.028
Estimation Comments Ratio calculated as T80-A5-H12.5 divided by T80-H12.5
7.Secondary Outcome
Title Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours
Hide Description Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state
Time Frame 0-6 hours (h), 6-12h and 12-24h after drug administration on day 10
Hide Outcome Measure Data
Hide Analysis Population Description
PK set
Arm/Group Title T80-A5-H12.5 T80-H12.5
Hide Arm/Group Description:
Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
Overall Number of Participants Analyzed 36 36
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mg
10.4
(11.4%)
9.9
(12.2%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80-A5-H12.5, T80-H12.5
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority limits: 80% − 125%
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The model included effects accounting for the following sources of variation: sequence, subjects within sequences, period and treatment.
Method of Estimation Estimation Parameter Adjusted geometric mean ratio (%)
Estimated Value 104.80
Confidence Interval (2-Sided) 90%
101.949 to 107.734
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.016
Estimation Comments Ratio calculated as T80-A5-H12.5 divided by T80-H12.5
Time Frame 10 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title T80-A5-H12.5 T80-H12.5 T80-A5 All Patients
Hide Arm/Group Description Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days. Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days

All participants in the study. Participants received three treatments in a randomised order

  • T80-A5-H12.5
  • T80-A5
  • T80-H12.5
All-Cause Mortality
T80-A5-H12.5 T80-H12.5 T80-A5 All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
T80-A5-H12.5 T80-H12.5 T80-A5 All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/34 (0.00%)   0/36 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
T80-A5-H12.5 T80-H12.5 T80-A5 All Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/36 (8.33%)   3/36 (8.33%)   2/34 (5.88%)   5/36 (13.89%) 
Investigations         
Alanine aminotransferase increased  1  3/36 (8.33%)  2/36 (5.56%)  2/34 (5.88%)  4/36 (11.11%) 
C-reactive protein increased  1  1/36 (2.78%)  1/36 (2.78%)  0/34 (0.00%)  2/36 (5.56%) 
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: NCT02183675     History of Changes
Other Study ID Numbers: 1348.5
First Submitted: July 7, 2014
First Posted: July 8, 2014
Results First Submitted: October 6, 2016
Results First Posted: November 30, 2016
Last Update Posted: November 30, 2016