Percentage of Participants Who Had One or More Adverse Events
Primary
· Up to Month 12
| Group | Value | 95% CI |
|---|---|---|
| Azilsartan/Amlodipine | 8.34 |
Last reviewed · How we verify
NCT02181816
Azilsartan/Amlodipine Combination Tablets LD & HD Specified Drug-use Survey "Long-term Use Survey"
Completed
Results posted
Last updated 3 June 2019
What this trial tests
trial testing Azilsartan/Amlodipine in Hypertension in 1,090 participants. Completed in 31 January 2017.
Timeline
26 June 2014
Primary endpoint
31 January 2017
31 January 2017
31 January 2017
Quick facts
| Lead sponsor | Takeda |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,090 |
| Start date | 26 June 2014 |
| Primary completion | 31 January 2017 |
| Estimated completion | 31 January 2017 |
| Sites | 2 locations across Japan |
Drugs / interventions tested
- Azilsartan/Amlodipine — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
Sponsor
Takeda — full company profile →
Who can join
Eligibility, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Systolic Office Blood Pressure
Secondary
· Baseline, Month 1, and final assessment point (up to Month 12)
Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
Baseline
| Group | Value | 95% CI |
|---|---|---|
| Azilsartan/Amlodipine | 149.5 | ± 19.13 |
Month 1
| Group | Value | 95% CI |
|---|---|---|
| Azilsartan/Amlodipine | 137.2 | ± 14.69 |
Final Assessment Point
| Group | Value | 95% CI |
|---|---|---|
| Azilsartan/Amlodipine | 133.0 | ± 14.14 |
Diastolic Office Blood Pressure
Secondary
· Baseline, Month 1, and final assessment point (up to Month 12)
Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.
Baseline
| Group | Value | 95% CI |
|---|---|---|
| Azilsartan/Amlodipine | 83.3 | ± 13.64 |
Month 1
| Group | Value | 95% CI |
|---|---|---|
| Azilsartan/Amlodipine | 77.4 | ± 11.35 |
Final Assessment Point
| Group | Value | 95% CI |
|---|---|---|
| Azilsartan/Amlodipine | 75.0 | ± 10.88 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Month 12. Reporting threshold: 0.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Azilsartan/Amlodipine
Serious: 16/1031 (2%)
Deaths: 6/1031
Serious adverse events (19 terms)
| Reaction | System | Azilsartan/Amlodipine |
|---|---|---|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Cholecystitis | Hepatobiliary disorders | — |
| Peritonitis | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Brain stem haemorrhage | Nervous system disorders | — |
| Cerebral infarction | Nervous system disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Prinzmetal angina | Cardiac disorders | — |
| Sinus node dysfunction | Cardiac disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Cholelithiasis | Hepatobiliary disorders | — |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | — |
| Renal disorder | Renal and urinary disorders | — |
| Death | General disorders | — |
| Sudden death | General disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Spinal compression fracture | Injury, poisoning and procedural complications | — |
Other adverse events (2 terms — click to expand)
| Reaction | System | Azilsartan/Amlodipine |
|---|---|---|
| Dizziness | Nervous system disorders | — |
| Blood creatinine increased | Investigations | — |
Most-reported serious reactions: Bile duct cancer, Cholecystitis, Peritonitis, Pneumonia, Plasma cell myeloma, Renal cancer, Brain stem haemorrhage, Cerebral infarction.
Data from ClinicalTrials.gov NCT02181816 adverse events section.
Sponsor's own description
The purpose of this survey is to evaluate the safety and efficacy of long-term use of azilsartan/amlodipine combination tablets Low Dose (LD) \& High Dose (HD) (Zacras Combination Tablets LD \& HD) in hypertensive patients in daily medical practice.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02181816
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02181816 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Takeda
- Last refreshed: 3 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02181816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing