Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension
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.
Timeline
- Start
- 2011-04
- Primary completion
- 2012-05
- Completion
- 2012-05
Outcome
Met primary endpoint
paper Both N and C contributed independently to SBP/DBP reductions [P < 0.0001 (RSM)]. PMID 25144296 ↗
paper all combinations providing statistically better blood pressure (BP) reductions from baseline versus respective monotherapies (P < 0.05) PMID 25144296 ↗
Publications
- Results Kjeldsen SE, Cha G, Villa G, Mancia G; DISTINCT Investigators. Nifedipine GITS/Candesartan Combination Therapy Lowers Blood Pressure Across Different Baseline Systolic and Diastolic Blood Pressure Categories: DISTINCT Study Subanalyses. J Clin Pharmacol. 2016 Sep;56(9):1120-9. doi: 10.1002/jcph.712. Epub 2016 Mar 7.
- Kjeldsen SE, Sica D, Haller H, Cha G, Gil-Extremera B, Harvey P, Heyvaert F, Lewin AJ, Villa G, Mancia G; DISTINCT Investigators. Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile: DISTINCT randomized trial results. J Hypertens. 2014 Dec;32(12):2488-98; discussion 2498. doi: 10.1097/HJH.0000000000000331.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Candesartan cilexetil | Unknown | 4 mg | — |
| Subject | Candesartan cilexetil | Unknown | 8 mg | — |
| Subject | Candesartan cilexetil | Unknown | 16 mg | — |
| Subject | Candesartan cilexetil | Unknown | 32 mg | — |
| Subject | Nifedipine | Other / unclassified | 20 mg | — |
| Subject | Nifedipine | Other / unclassified | 30 mg | — |
| Subject | Nifedipine | Other / unclassified | 60 mg | — |