drugset / Trial / NCT00649389
Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
RandomizedParallel-groupDouble-blindTreatment
Summary
To determine the effectiveness of four different strength combinations of three approved anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for lowering blood pressure.
Timeline
- Start
- 2008-05
- Primary completion
- 2009-04
- Completion
- 2009-12
Publications
- Kereiakes DJ, Chrysant SG, Izzo JL Jr, Littlejohn T 3rd, Melino M, Lee J, Fernandez V, Heyrman R. Olmesartan/amlodipine/hydrochlorothiazide in participants with hypertension and diabetes, chronic kidney disease, or chronic cardiovascular disease: a subanalysis of the multicenter, randomized, double-blind, parallel-group TRINITY study. Cardiovasc Diabetol. 2012 Oct 30;11:134. doi: 10.1186/1475-2840-11-134.
- Chrysant SG, Littlejohn T 3rd, Izzo JL Jr, Kereiakes DJ, Oparil S, Melino M, Lee J, Fernandez V, Heyrman R. Triple-Combination therapy with olmesartan, amlodipine, and hydrochlorothiazide in black and non-black study participants with hypertension: the TRINITY randomized, double-blind, 12-week, parallel-group study. Am J Cardiovasc Drugs. 2012 Aug 1;12(4):233-43. doi: 10.1007/BF03261832.
- Oparil S, Melino M, Lee J, Fernandez V, Heyrman R. Triple therapy with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide in adult patients with hypertension: The TRINITY multicenter, randomized, double-blind, 12-week, parallel-group study. Clin Ther. 2010 Jul;32(7):1252-69. doi: 10.1016/j.clinthera.2010.07.008.
- Chrysant SG, Oparil S, Melino M, Karki S, Lee J, Heyrman R. Efficacy and safety of long-term treatment with the combination of amlodipine besylate and olmesartan medoxomil in patients with hypertension. J Clin Hypertens (Greenwich). 2009 Sep;11(9):475-82. doi: 10.1111/j.1751-7176.2009.00159.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 10 mg | — |
| Comparator | Hydrochlorothiazide | Unknown | 25 mg | — |
| Subject | Olmesartan medoxomil | Unknown | 40 mg | — |