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NCT01303783 · ClinicalTrials.gov registry record · Phase 2
Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,381
- Enrollment target
NCT01303783 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 1,381 participants.
The verdict
NCT01303783, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,381 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are currently approved for use in patients with essential hypertension alone or together with other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS and candesartan used together in the treatment of essential hypertension has not been established yet. In this study patients will be treated with various doses of nifedipine GITS and/or candesartan or placebo. These different regimens will be administered once a day and will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood pressure) in subjects with mild to moderate essential hypertension.
Interventions
- DRUG Candesartan cilexetil (Atacand), 4 mg
- DRUG Candesartan cilexetil (Atacand), 8 mg
- DRUG Nifedipine GITS (Adalat, BAYA1040), 20 mg
- DRUG Nifedipine GITS (Adalat, BAYA1040), 30 mg
- DRUG Nifedipine GITS (Adalat, BAYA1040), 60 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,381 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01303783
The ClinicalTrials.gov registry entry for NCT01303783 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,381 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 5 interventions - of which Candesartan cilexetil (Atacand), 4 mg is the first listed.
NCT01303783 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01303783 about?
NCT01303783 is a clinical study titled "Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension". The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active ingredient). The drugs - nifedipine ...
What is the current status of trial NCT01303783?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,381 participants. The study started on 2011-04. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01303783?
The interventions under investigation include: Candesartan cilexetil (Atacand), 4 mg (DRUG), Candesartan cilexetil (Atacand), 8 mg (DRUG), Nifedipine GITS (Adalat, BAYA1040), 20 mg (DRUG), Nifedipine GITS (Adalat, BAYA1040), 30 mg (DRUG), Nifedipine GITS (Adalat, BAYA1040), 60 mg (DRUG).
Who is sponsoring clinical trial NCT01303783?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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