drugset / Trial / NCT00000522
Treatment of Mild Hypertension Study (TOMHS)
Phase 2
Completed
University of Minnesota
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedTreatment
Summary
To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
Timeline
- Start
- 1985-08
- Primary completion
- —
- Completion
- 1994-05
Publications
- Background Mascioli SR, Grimm RH Jr, Neaton JD, Stamler J, Prineas RJ, Cutler JA, Elmer PJ, McDonald R, Schnaper H, Schoenberger J. Characteristics of participants at baseline in the Treatment of Mild Hypertension Study (TOMHS). Am J Cardiol. 1990 Sep 25;66(9):32C-35C. doi: 10.1016/0002-9149(90)90760-x.
- Background The treatment of mild hypertension study. A randomized, placebo-controlled trial of a nutritional-hygienic regimen along with various drug monotherapies. The Treatment of Mild Hypertension Research Group. Arch Intern Med. 1991 Jul;151(7):1413-23. doi: 10.1001/archinte.151.7.1413.
- Background Liebson PR, Grandits G, Prineas R, Dianzumba S, Flack JM, Cutler JA, Grimm R, Stamler J. Echocardiographic correlates of left ventricular structure among 844 mildly hypertensive men and women in the Treatment of Mild Hypertension Study (TOMHS). Circulation. 1993 Feb;87(2):476-86. doi: 10.1161/01.cir.87.2.476.
- Background Neaton JD, Grimm RH Jr, Prineas RJ, Stamler J, Grandits GA, Elmer PJ, Cutler JA, Flack JM, Schoenberger JA, McDonald R, et al. Treatment of Mild Hypertension Study. Final results. Treatment of Mild Hypertension Study Research Group. JAMA. 1993 Aug 11;270(6):713-24.
- Background Black HR. Treatment of mild hypertension. The more things change.. JAMA. 1993 Aug 11;270(6):757-9. No abstract available.
- Background Flack JM, Neaton JD, Daniels B, Esunge P. Ethnicity and renal disease: lessons from the Multiple Risk Factor Intervention Trial and the Treatment of Mild Hypertension Study. Am J Kidney Dis. 1993 Apr;21(4 Suppl 1):31-40. doi: 10.1016/s0272-6386(12)80859-6.
- Background Elmer PJ, Grimm R Jr, Laing B, Grandits G, Svendsen K, Van Heel N, Betz E, Raines J, Link M, Stamler J, et al. Lifestyle intervention: results of the Treatment of Mild Hypertension Study (TOMHS). Prev Med. 1995 Jul;24(4):378-88. doi: 10.1006/pmed.1995.1062.
- Background Stamler J, Prineas RJ, Neaton JD, Grimm RH, McDonald RH, Schnaper HW, Schoenberger JA, Elmer PJ, Cutler JA. Background and design of the new U.S. trial on diet and drug treatment of "mild" hypertension (TOMHS). Am J Cardiol. 1987 May 29;59(14):51G-60G. doi: 10.1016/0002-9149(87)90158-5.
- Background Prineas RJ, Grimm R, Grandits G, et al: The Effect of Dietary Sodium and Body Weight on Echocardiographic Measures of Left Ventricular Mass Among Treated Hypertensive Men and Women: Four-Year Change in the TOMHS Study. Nieren-und Hochdruck-krankheiten, Jahrgang 23:S14-S21, 1994.
- Background Grandits GA, Liebson PR, Dianzumba S, Prineas RJ. Echocardiography in multicenter clinical trials: experience from the Treatment of Mild Hypertension Study. Control Clin Trials. 1994 Oct;15(5):395-410. doi: 10.1016/0197-2456(94)90035-3.
- Background Liebson PR, Grandits GA, Dianzumba S, Prineas RJ, Grimm RH Jr, Neaton JD, Stamler J. Comparison of five antihypertensive monotherapies and placebo for change in left ventricular mass in patients receiving nutritional-hygienic therapy in the Treatment of Mild Hypertension Study (TOMHS). Circulation. 1995 Feb 1;91(3):698-706. doi: 10.1161/01.cir.91.3.698.
- Background Crow RS, Prineas RJ, Rautaharju P, Hannan P, Liebson PR. Relation between electrocardiography and echocardiography for left ventricular mass in mild systemic hypertension (results from Treatment of Mild Hypertension Study). Am J Cardiol. 1995 Jun 15;75(17):1233-8.
- Background Grimm RH Jr, Flack JM, Grandits GA, Elmer PJ, Neaton JD, Cutler JA, Lewis C, McDonald R, Schoenberger J, Stamler J. Long-term effects on plasma lipids of diet and drugs to treat hypertension. Treatment of Mild Hypertension Study (TOMHS) Research Group. JAMA. 1996 May 22-29;275(20):1549-56. doi: 10.1001/jama.1996.03530440029033.
- Background Grimm RH Jr, Grandits GA, Prineas RJ, McDonald RH, Lewis CE, Flack JM, Yunis C, Svendsen K, Liebson PR, Elmer PJ. Long-term effects on sexual function of five antihypertensive drugs and nutritional hygienic treatment in hypertensive men and women. Treatment of Mild Hypertension Study (TOMHS). Hypertension. 1997 Jan;29(1 Pt 1):8-14. doi: 10.1161/01.hyp.29.1.8.
- Background Lewis CE, Grandits A, Flack J, McDonald R, Elmer PJ. Efficacy and tolerance of antihypertensive treatment in men and women with stage 1 diastolic hypertension. Results of the Treatment of Mild Hypertension Study. Arch Intern Med. 1996 Feb 26;156(4):377-85.
- Background Grimm RH Jr, Grandits GA, Cutler JA, Stewart AL, McDonald RH, Svendsen K, Prineas RJ, Liebson PR. Relationships of quality-of-life measures to long-term lifestyle and drug treatment in the Treatment of Mild Hypertension Study. Arch Intern Med. 1997 Mar 24;157(6):638-48.
- Background Ganguli MC, Grimm RH Jr, Svendsen KH, Flack JM, Grandits GA, Elmer PJ. Urinary sodium and potassium profile of blacks and whites in relation to education in two different geographic urban areas. TOMHS Research Group. Treatment of Mild Hypertension Study. Am J Hypertens. 1999 Jan;12(1 Pt 1):69-72. doi: 10.1016/s0895-7061(98)00218-0.
- Background Ganguli MC, Grimm RH Jr, Svendsen KH, Flack JM, Grandits GA, Elmer PJ. Higher education and income are related to a better Na:K ratio in blacks: baseline results of the Treatment of Mild Hypertension Study (TOMHS) data. Am J Hypertens. 1997 Sep;10(9 Pt 1):979-84. doi: 10.1016/s0895-7061(97)00162-3.
- Background Grandits GA, Grimm RH Jr, Prineas RJ, Grambsch P, Holland LA. Obtaining event status at the close of the Treatment of Mild Hypertension Study: methods and implication for other trials. Control Clin Trials. 2001 Feb;22(1):56-61. doi: 10.1016/s0197-2456(00)00121-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | — | — |
| Subject | Chlorthalidone | Other / unclassified | — | — |
| Subject | Doxazosin | Small molecule | — | — |
| Subject | Enalapril | Other / unclassified | — | — |
| Subject | acebutolol | Small molecule | — | — |