Trial · NCT01788358
Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
NCT01788358, Phase 3, Completed, Bayer; results first posted 2015-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension. Trials, record NCT01788358. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01788358
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
- NCT number
- NCT01788358
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 508 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Hypertension
- Interventions
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
- First posted
- 2013-02-11
- Last updated
- 2017-10-24
- Other registries' IDs
- eudract:2012-004515-32
- Results first posted
- 2015-08-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28 | From the time of first study drug administration up to Week 28 | An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. |
| Primary | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | From the time of first study drug administration up to Week 28 | An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported. |
| Primary | Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS) | From the time of first study drug administration up to Week 52/EOS | An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. |
| Primary | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS) | From the time of study treatment up to Week 52/EOS | An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported. |
| Secondary | Number of Subjects With Clinically Relevant Changes in Laboratory Parameters | Baseline (Week 0) up to Week 52/EOS | Laboratory evaluations of blood and urine samples were performed, including hematology (hematocrit, hemoglobin, red blood cells count, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), blood chemistry (sodium, potassium, chloride, bicarbonate, uric acid, total protein, albumin, calcium, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, creatine kinase, total bilirubin, direct bilirubin, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, fasting glucose), urinalysis (pH, blood, specific gravity, glucose, protein, cells/sediment). A laboratory test abnormality considered clinically relevant, for example, causing withdrawal by subject, requiring treatment or causing apparent clinical manifestations, or judged relevant by the investigator, were reported as AEs. |
| Secondary | Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52 | Baseline (Week 0), Weeks 28 and 52 | |
| Secondary | Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52 | Baseline (Week 0), Weeks 28 and 52 | |
| Secondary | Blood Pressure Control Rate at Weeks 28 and 52 | Weeks 28 and 52 | Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (\<) 140/90 mmHg. |
| Secondary | Blood Pressure Response Rate at Weeks 28 and 52 | Weeks 28 and 52 | Response rate was defined as the percentage of subjects who achieved a systolic blood pressure response (MSSBP of \<140 mmHg or a reduction of MSSBP of more than (\>) 20 mmHg from baseline value), or a diastolic blood pressure response (MSDBP of \<90 mmHg or a reduction of MSDBP of \>10 mmHg from baseline value). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28 | From the time of first study drug administration up to Week 28 | Safety Analysis Set (SAF): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication. | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | From the time of first study drug administration up to Week 28 | SAF | Subjects | NUMBER |
| PRIMARY | Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS) | From the time of first study drug administration up to Week 52/EOS | SAF | Subjects | NUMBER |
| PRIMARY | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS) | From the time of study treatment up to Week 52/EOS | SAF | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Clinically Relevant Changes in Laboratory Parameters | Baseline (Week 0) up to Week 52/EOS | SAF | Subjects | NUMBER |
| SECONDARY | Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52 | Baseline (Week 0), Weeks 28 and 52 | Modified intention-to-treat analysis set (mITT): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication. | millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52 | Baseline (Week 0), Weeks 28 and 52 | mITT | millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Blood Pressure Control Rate at Weeks 28 and 52 | Weeks 28 and 52 | mITT | percentage of subjects | NUMBER |
| SECONDARY | Blood Pressure Response Rate at Weeks 28 and 52 | Weeks 28 and 52 | mITT | percentage of subjects | NUMBER |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | All TEAEs | 390 | Subjects | |
| Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | Drug-related TEAEs | 230 | Subjects | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | Oedema (mild) | 124 | Subjects | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | Oedema (moderate) | 54 | Subjects | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | Oedema (severe) | 7 | Subjects | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | Headache (mild) | 31 | Subjects | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | Headache (moderate) | 15 | Subjects | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | Flushing (mild) | 3 | Subjects | |
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | Symptomatic hypotension (mild) | 4 | Subjects | |
| Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS) | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | All TEAEs | 404 | Subjects |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 508 | |
| Overall Study | Treated | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 508 | |
| Overall Study | Completed Week 28 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 417 | |
| Overall Study | Entered Extension to Week 52 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 200 | |
| Overall Study | Completed Week 52 | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 193 | |
| Overall Study | COMPLETED | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 410 | |
| Overall Study | NOT COMPLETED | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 98 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 18 | 508 | 20 |
| other | Oedema | General disorders | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 55 | 508 | 80 |
| other | Oedema peripheral | General disorders | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 150 | 508 | 239 |
| other | Nasopharyngitis | Infections and infestations | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 27 | 508 | 30 |
| other | Upper respiratory tract infection | Infections and infestations | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 25 | 508 | 29 |
| other | Dizziness | Nervous system disorders | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 47 | 508 | 55 |
| other | Headache | Nervous system disorders | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 47 | 508 | 60 |
| serious | Aplastic anaemia | Blood and lymphatic system disorders | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 1 | 508 | 1 |
| serious | Acute myocardial infarction | Cardiac disorders | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 1 | 508 | 1 |
| serious | Coronary artery disease | Cardiac disorders | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 1 | 508 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | ||
| Total, other adverse events | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 279 | 508 |
| Total, serious adverse events | Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106) | 15 | 508 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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