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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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 508 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01788358
The ClinicalTrials.gov registry entry for NCT01788358 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 508 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) is the first listed.
NCT01788358 reports 0 study locations.
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.
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