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To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients with essential hypertension who failed to control their BP with either monotherapy
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan40/amlodipine5 | Drug | |||
| telmisartan80/amlodipine5 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Adverse Events | An adverse event is defined as any untoward medical occurrence | 52 weeks |
| Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG | 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. | First administration of study treatment to 24 hours post last dosing of study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Seated Diastolic Blood Pressure at Week 8 | mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure | Baseline and week 8 |
| Change From Baseline in Seated Systolic Blood Pressure at Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1235.16.004 Boehringer Ingelheim Investigational Site | Chofu, Tokyo | Japan | ||||
| 1235.16.006 Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | |
| FG001 | Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination | |
| BG001 | Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Adverse Events | An adverse event is defined as any untoward medical occurrence | Treated set for safety, which was the analysis set including all the patients who had valid measurements after drug administration. | Posted | Number | percentage of participants | 52 weeks |
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|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
| Baseline and week 8 |
| Seated DBP Control Rate at Trough After 8 Weeks | Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment | week 8 |
| Seated SBP Control Rate at Trough After 8 Weeks | Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment | Week 8 |
| Change From Baseline in Seated Diastolic Blood Pressure | Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure | Baseline and week 20 / week 48 |
| Change From Baseline in Seated Systolic Blood Pressure | mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure | Baseline and week 20 / week 48 |
| Seated DBP Control Rate at Trough After 6 and 12 Months | Percentage of patients whose DBP <90 mmHg. | 6 months and 12 months |
| Seated SBP Control Rate at Trough After 6 and 12 Months | Percentage of patients whose SBP <140 mmHg | 6 months and 12 months |
| Seated DBP Response Rate at Trough | Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months | 6 months and 12 months |
| Seated SBP Response Rate at Trough | Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months | 6 months and 12 months |
| Seated Blood Pressure Normalisation at Trough | 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 | 6 months and 12 months |
| Nishi-ku, Hiroshima, Hiroshima |
| Japan |
| 1235.16.005 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1235.16.007 Boehringer Ingelheim Investigational Site | Osaka, Osaka | Japan |
| 1235.16.003 Boehringer Ingelheim Investigational Site | Shinjuku-ku, Tokyo | Japan |
| 1235.16.001 Boehringer Ingelheim Investigational Site | Shinjyuku-ku,Tokyo | Japan |
| 1235.16.002 Boehringer Ingelheim Investigational Site | Suita, Osaka | Japan |
Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Change From Baseline in Seated Diastolic Blood Pressure at Week 8 | mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and week 8 |
|
|
|
| Secondary | Change From Baseline in Seated Systolic Blood Pressure at Week 8 | mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and week 8 |
|
|
|
| Secondary | Seated DBP Control Rate at Trough After 8 Weeks | Percentage of patients whose DBP <90 mmHg after 8 weeks of treatment | FAS | Posted | Number | percentage of participants | week 8 |
|
|
|
| Secondary | Seated SBP Control Rate at Trough After 8 Weeks | Percentage of patients whose SBP <140 mmHg after 8 weeks of treatment | FAS | Posted | Number | percentage of participants | Week 8 |
|
|
|
| Secondary | Change From Baseline in Seated Diastolic Blood Pressure | Mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and week 20 / week 48 |
|
|
|
| Secondary | Change From Baseline in Seated Systolic Blood Pressure | mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline and week 20 / week 48 |
|
|
|
| Secondary | Seated DBP Control Rate at Trough After 6 and 12 Months | Percentage of patients whose DBP <90 mmHg. | FAS | Posted | Number | percentage of participants | 6 months and 12 months |
|
|
|
| Secondary | Seated SBP Control Rate at Trough After 6 and 12 Months | Percentage of patients whose SBP <140 mmHg | FAS | Posted | Number | percentage of participants | 6 months and 12 months |
|
|
|
| Secondary | Seated DBP Response Rate at Trough | Percentage of patients whose DBP <90 mmHg or decreased from pseudo-baseline by >=10 mmHg at 6 months and 12 months | FAS | Posted | Number | percentage of participants | 6 months and 12 months |
|
|
|
| Secondary | Seated SBP Response Rate at Trough | Percentage of patients whose SBP <140 mmHg or decreased deom pseudo-baseline by >=20 mmHg after 6 and 12 months | FAS | Posted | Number | percentage of participants | 6 months and 12 months |
|
|
|
| Secondary | Seated Blood Pressure Normalisation at Trough | 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 | FAS | Posted | Number | percentage of participants | 6 months and 12 months |
|
|
|
| Primary | Clinically Relevant Abnormalities for Changes in Blood Pressure and Pulse Rate Due to Position Change, Seated Pulse Rate, Laboratory Parameters and ECG | 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. | Treated set | Posted | Number | participants | First administration of study treatment to 24 hours post last dosing of study treatment. |
|
|
|
| 9 |
| 211 |
| 102 |
| 211 |
| EG001 | Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination | 3 | 48 | 23 | 48 |
| Prostatic specific antigen increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Renal haemorrhage | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
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.
| Week 20: High Normal |
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| Week 20: No |
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| Week 48: Optimal |
|
| Week 48: Normal |
|
| Week 48: High Normal |
|
| Week 48: No |
|
| Acute myocardial infarction |
|
| Arrhythmia |
|
| Atrial fibrillation |
|
| Extrasystoles |
|
| Ventricular extrasystoles |
|
| Orthostatic hypotension |
|