Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01788358 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 508
- Enrollment target
NCT01788358: Completed Phase 3 study, sponsored by Bayer.
NCT01788358 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 508 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01788358, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 508 participants
- Enrollment target
Study Summary
This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension. Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total). Subjects who do not tolerate an increased dose will be treated at their highest tolerable dose.
Primary Outcome
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.
Interventions
- DRUG Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 508 participants |
| Start Date | 2013-02-14 |
| Est. Completion | 2014-05-01 |
| Phase | Phase 3 |
What the finished NCT01788358 record still lists
NCT01788358 is an interventional study that assigns participants to a tested intervention. The registered 508 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 1 intervention - of which Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) is the first listed.
NCT01788358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01788358 about?
NCT01788358 is a clinical study titled "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". This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension. Patients meeting the entry criteria, will receive the Fixed Dose combination fo...
What is the current status of trial NCT01788358?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 508 participants. The study started on 2013-02-14. Estimated completion is 2014-05-01.
What interventions are being tested in trial NCT01788358?
The interventions under investigation include: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) (DRUG).
Who is sponsoring clinical trial NCT01788358?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01788358's enrollment target sits among peer trials
508 737th of 2000 higher than 1,262 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02115295 · 508 participants · Phase 2
Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia
- NCT04692675 · 508 participants · NA
Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer
- NCT07391657 · 508 participants · Phase 3
A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
- NCT07484217 · 508 participants · Phase 3
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI