drugset / Trial / NCT03640312
Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension
Phase 2
Completed
62 enrolled
Washington University School of Medicine
ACCESS Community Health Network · collabUniversity of Sydney · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To investigate, in a double-blind randomized controlled trial, whether initiating treatment with ultra-low-dose quadruple-combination therapy ("LDQT") will lower office blood pressure more effectively, and with fewer side effects, compared to initiating standard dose monotherapy as per current guidelines in patients with hypertension. Primary hypothesis: A combination pill comprising four types of blood pressure lowering medications, each at one-quarter standard doses, will lower office blood pressure more effectively than initiating patients with standard dose monotherapy as per contemporary clinical practice guideline recommendations.
Timeline
- Start
- 2019-08-30
- Primary completion
- 2022-05-31
- Completion
- 2024-07-31
Publications
- Huffman MD, Baldridge AS, Lazar D, Abbas H, Mejia J, Flowers FM, Quintana A, Jackson A, Kandula NR, Lloyd-Jones DM, Persell SD, Khan SS, Paparello JJ, Chopra A, Tripathi P, Vu MH, Chow CK, Ciolino JD. Efficacy and safety of a four-drug, quarter-dose treatment for hypertension: the QUARTET USA randomized trial. Hypertens Res. 2024 Jun;47(6):1668-1677. doi: 10.1038/s41440-024-01658-y. Epub 2024 Apr 8.
- Sanuade OA, Jacobson TA, Quintana A, Flowers FM, Abbasi H, Vu MH, Baldridge AS, Mejia J, Lazar D, Ciolino JD, Huffman MD, Kandula NR. Process Evaluation of a Double-Blind Randomized Controlled Trial to Assess the Efficacy and Safety of a Quadruple Ultra-Low-Dose Treatment for Hypertension Within a Federally Qualified Health Center Network (QUARTET USA). J Am Heart Assoc. 2024 Jan 2;13(1):e032236. doi: 10.1161/JAHA.123.032236. Epub 2023 Dec 29.
- Baldridge AS, Huffman MD, Lazar D, Abbas H, Flowers FM, Quintana A, Jackson A, Khan SS, Chopra A, Vu M, Tripathi P, Jacobson T, Sanuade OA, Kandula NR, Persell SD, Paparello JJ, Rosul LL, Mejia J, Lloyd-Jones DM, Chow CK, Ciolino JD. Efficacy and safety of a quadruple ultra-low-dose treatment for hypertension (QUARTET USA): Rationale and design for a randomized controlled trial. Am Heart J. 2022 Dec;254:183-193. doi: 10.1016/j.ahj.2022.09.004. Epub 2022 Sep 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | 1.25 mg | — |
| Subject | Bisoprolol | Other / unclassified | 2.5 mg | — |
| Comparator | Candesartan | Unknown | 2 mg | — |
| Comparator | Candesartan | Unknown | 8 mg | — |
| Subject | Indapamide | Small molecule | 0.625 mg | — |