Trial Outcomes & Findings for An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination (NCT NCT00618774)
NCT ID: NCT00618774
Last Updated: 2014-06-27
Results Overview
An adverse event is defined as any untoward medical occurrence
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
259 participants
Primary outcome timeframe
52 weeks
Results posted on
2014-06-27
Participant Flow
Participant milestones
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
|
|---|---|---|
|
Overall Study
STARTED
|
211
|
48
|
|
Overall Study
COMPLETED
|
205
|
45
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
Baseline characteristics by cohort
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=211 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
51.1 Years
STANDARD_DEVIATION 8 • n=7 Participants
|
55.8 Years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration.
An adverse event is defined as any untoward medical occurrence
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=211 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Percentage of Participants Who Experienced Adverse Events
|
77.3 percentage of participants
|
77.1 percentage of participants
|
PRIMARY outcome
Timeframe: First administration of study treatment to 24 hours post last dosing of study treatment.Population: Treated set
Clinically relevant abnormalities for changes in blood pressure and pulse rate due to position change, seated pulse rate, laboratory parameters and ECG. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=211 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Blood Pressure Decreased
|
2 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Prostatic specific antigen increased
|
1 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Acute myocardial infarction
|
0 participants
|
1 participants
|
|
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Arrhythmia
|
1 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Atrial fibrillation
|
2 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Extrasystoles
|
1 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Ventricular extrasystoles
|
1 participants
|
0 participants
|
|
Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG
Orthostatic hypotension
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and week 8Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.
mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Change From Baseline in Seated Diastolic Blood Pressure at Week 8
|
20.81 mmHg
Standard Deviation 6.65
|
15.75 mmHg
Standard Deviation 6.61
|
SECONDARY outcome
Timeframe: Baseline and week 8Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.
mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Change From Baseline in Seated Systolic Blood Pressure at Week 8
|
33.89 mmHg
Standard Deviation 12.2
|
26.44 mmHg
Standard Deviation 11.68
|
SECONDARY outcome
Timeframe: week 8Population: FAS
Percentage of patients whose DBP \<90 mmHg after 8 weeks of treatment
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Seated DBP Control Rate at Trough After 8 Weeks
|
91.8 percentage of participants
|
52.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: FAS
Percentage of patients whose SBP \<140 mmHg after 8 weeks of treatment
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Seated SBP Control Rate at Trough After 8 Weeks
|
93.2 percentage of participants
|
85.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 20 / week 48Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.
Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Change From Baseline in Seated Diastolic Blood Pressure
Week 20
|
20.67 mmHg
Standard Deviation 7.16
|
16.36 mmHg
Standard Deviation 5.93
|
|
Change From Baseline in Seated Diastolic Blood Pressure
Week 48
|
21.39 mmHg
Standard Deviation 6.6
|
17.78 mmHg
Standard Deviation 7.31
|
SECONDARY outcome
Timeframe: Baseline and week 20 / week 48Population: Full analysis set for blood pressure measurements, which was the analysis set including all the patients who had valid measurements at the reference baseline and at one or more time-points after reference baseline.
mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Change From Baseline in Seated Systolic Blood Pressure
Week 20
|
33.73 mmHg
Standard Deviation 12.55
|
27.18 mmHg
Standard Deviation 11.83
|
|
Change From Baseline in Seated Systolic Blood Pressure
Week 48
|
33.97 mmHg
Standard Deviation 11.75
|
28.11 mmHg
Standard Deviation 12.78
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: FAS
Percentage of patients whose DBP \<90 mmHg.
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Seated DBP Control Rate at Trough After 6 and 12 Months
Week 20
|
90.8 percentage of participants
|
54.2 percentage of participants
|
|
Seated DBP Control Rate at Trough After 6 and 12 Months
Week 48
|
92.8 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: FAS
Percentage of patients whose SBP \<140 mmHg
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Seated SBP Control Rate at Trough After 6 and 12 Months
Week 20
|
95.7 percentage of participants
|
89.6 percentage of participants
|
|
Seated SBP Control Rate at Trough After 6 and 12 Months
Week 48
|
93.2 percentage of participants
|
89.6 percentage of participants
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: FAS
Percentage of patients whose DBP \<90 mmHg or decreased from pseudo-baseline by \>=10 mmHg at 6 months and 12 months
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Seated DBP Response Rate at Trough
Week 20
|
97.1 percentage of participants
|
85.4 percentage of participants
|
|
Seated DBP Response Rate at Trough
Week 48
|
98.6 percentage of participants
|
87.5 percentage of participants
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: FAS
Percentage of patients whose SBP \<140 mmHg or decreased deom pseudo-baseline by \>=20 mmHg after 6 and 12 months
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Seated SBP Response Rate at Trough
Week 20
|
97.6 percentage of participants
|
93.8 percentage of participants
|
|
Seated SBP Response Rate at Trough
Week 48
|
97.6 percentage of participants
|
93.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 months and 12 monthsPopulation: FAS
Percentage of patients when classifying their blood pressure measurements into the following classes at 6 and 12 months: Optimal: SBP \<120 mmHg and DBP \<80 mmHg Normal: SBP \>=120 mmHg or DBP \>=80 mmHg and SBP \<130 mmHg or DBP \<85 mmHg High normal: SBP \>=130 mmHg or DBP \>=85 mmHg and SBP \<140 mmHg or DBP \<90 mmHg No: SBP \>=140 mmHg or DBP \>=90 mmHg
Outcome measures
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=207 Participants
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 Participants
|
|---|---|---|
|
Seated Blood Pressure Normalisation at Trough
Week 20: Optimal
|
29.5 percentage of participants
|
4.2 percentage of participants
|
|
Seated Blood Pressure Normalisation at Trough
Week 20: Normal
|
35.3 percentage of participants
|
18.8 percentage of participants
|
|
Seated Blood Pressure Normalisation at Trough
Week 20: High Normal
|
24.2 percentage of participants
|
31.3 percentage of participants
|
|
Seated Blood Pressure Normalisation at Trough
Week 20: No
|
11.1 percentage of participants
|
45.8 percentage of participants
|
|
Seated Blood Pressure Normalisation at Trough
Week 48: Optimal
|
32.4 percentage of participants
|
6.3 percentage of participants
|
|
Seated Blood Pressure Normalisation at Trough
Week 48: Normal
|
36.2 percentage of participants
|
18.8 percentage of participants
|
|
Seated Blood Pressure Normalisation at Trough
Week 48: High Normal
|
18.4 percentage of participants
|
39.6 percentage of participants
|
|
Seated Blood Pressure Normalisation at Trough
Week 48: No
|
13.0 percentage of participants
|
35.4 percentage of participants
|
Adverse Events
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
Serious events: 9 serious events
Other events: 102 other events
Deaths: 0 deaths
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=211 participants at risk
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Investigations
Prostatic specific antigen increased
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Nervous system disorders
Epilepsy
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Renal and urinary disorders
Renal cyst
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.47%
1/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
0.00%
0/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
2.1%
1/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
2.1%
1/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
2.1%
1/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
Other adverse events
| Measure |
Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=211 participants at risk
|
Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination
n=48 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Dental caries
|
5.7%
12/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
6.2%
3/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Infections and infestations
Nasopharyngitis
|
43.1%
91/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
41.7%
20/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
18/211 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
4.2%
2/48 • While being treated with T20+A5, T40/A5, T80/A5, T40/A5+additional treatment, T80/A5+additional treatment and within 24 hours from the last dosing of any of them.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER