Number of Participants Who Experience at Least One Adverse Events
Primary
· Up to 12 Months
| Group | Value | 95% CI |
|---|---|---|
| Candesartan Cilexetil/Amlodipine | 286 |
Last reviewed · How we verify
NCT02068495
Candesartan Cilexetil/Amlodipine Besilate Combination Tablets LD, HD Special Drug Use Surveillance "Hypertension: Long-Term Use"
Completed
Results posted
Last updated 26 July 2018
What this trial tests
trial testing Candesartan cilexetil/Amlodipine besilate in Hypertension in 3,409 participants. Completed in 31 May 2013.
Timeline
15 June 2010
Primary endpoint
31 May 2013
31 May 2013
31 May 2013
Quick facts
| Lead sponsor | Takeda |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 3,409 |
| Start date | 15 June 2010 |
| Primary completion | 31 May 2013 |
| Estimated completion | 31 May 2013 |
Drugs / interventions tested
- Candesartan cilexetil/Amlodipine besilate — 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.
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Primary
· Up to 12 Months
ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
| Group | Value | 95% CI |
|---|---|---|
| Candesartan Cilexetil/Amlodipine | 85 |
Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment
Secondary
· Baseline and final assessment (up to 12 Months)
Reported data are changes in SBP from baseline at final assessment (up to 12 months).
| Group | Value | 95% CI |
|---|---|---|
| Candesartan Cilexetil/Amlodipine | -14.6 | ± 19.6 |
Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment
Secondary
· Baseline and final assessment (up to 12 Months)
Reported data are changes in DBP from baseline at final assessment (up to 12 months).
| Group | Value | 95% CI |
|---|---|---|
| Candesartan Cilexetil/Amlodipine | -7.2 | ± 12.3 |
Changes From Baseline in Pulse Rate at Final Assessment
Secondary
· Baseline and final assessment (up to 12 Months)
Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months).
| Group | Value | 95% CI |
|---|---|---|
| Candesartan Cilexetil/Amlodipine | -1.2 | ± 10.2 |
Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment
Secondary
· Baseline and final assessment (up to 12 Months)
Reported data are percentage of participants who meet targeted blood pressure level at baseline and final assessment in analysis population. Targeted blood pressure level of SBP/DBP was less than 140/90 mmHg.
Baseline
| Group | Value | 95% CI |
|---|---|---|
| Candesartan Cilexetil/Amlodipine | 28.5 |
Final Assessment
| Group | Value | 95% CI |
|---|---|---|
| Candesartan Cilexetil/Amlodipine | 66.9 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 12 Months. Reporting threshold: 0.3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Candesartan Cilexetil/Amlodipine
Serious: 63/3300 (2%)
Deaths: —
Serious adverse events (58 terms)
| Reaction | System | Candesartan Cilexetil/Amlo… |
|---|---|---|
| Pneumonia | Infections and infestations | — |
| Spinal compression fracture | Injury, poisoning and procedural complications | — |
| Marasmus | Metabolism and nutrition disorders | — |
| Cerebral infarction | Nervous system disorders | — |
| Cardiac failure | Cardiac disorders | — |
| Peritonitis | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | — |
| Renal failure | Renal and urinary disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Pyelonephritis | Infections and infestations | — |
| Infectious pleural effusion | Infections and infestations | — |
| Appendicitis | Infections and infestations | — |
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Liver carcinoma ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — |
| Completed suicide | Psychiatric disorders | — |
| Dementia Alzheimer's type | Nervous system disorders | — |
Other adverse events (6 terms — click to expand)
| Reaction | System | Candesartan Cilexetil/Amlo… |
|---|---|---|
| Blood pressure decreased | Investigations | — |
| Hepatic function abnormal | Hepatobiliary disorders | — |
| Blood urea increased | Investigations | — |
| Dizziness | Nervous system disorders | — |
| Gamma-glutamyltransferase increased | Investigations | — |
| Blood creatinine increased | Investigations | — |
Most-reported serious reactions: Pneumonia, Spinal compression fracture, Marasmus, Cerebral infarction, Cardiac failure, Peritonitis, Urinary tract infection, Breast cancer.
Data from ClinicalTrials.gov NCT02068495 adverse events section.
Sponsor's own description
The purpose of this survey is to investigate the safety and efficacy of long-term use of candesartan cilexetil/amlodipine besilate combination tablets (Unisia Combination Tablets) low dose (LD), high dose (HD) in participants with hypertension in the normal clinical setting.
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 NCT02068495
- 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 NCT02068495 (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: 26 July 2018
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/NCT02068495.
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