NCT03928145

Efficacy of Chlorthalidone and Hydrochlorothiazide in Combination With Amiloride in Multiple Doses on Blood Pressure in Patients With Primary Hypertension: a Factorial Randomized Controlled Trial.

Status unknown Phase 3 Last updated 6 December 2019

What this trial tests

Phase 3 trial testing Chlorthalidone 25 mg in Hypertension in 84 participants. Status unknown.

Timeline

13 November 2019

Primary endpoint
1 July 2021

1 July 2021

Quick facts

Lead sponsor	Hospital de Clinicas de Porto Alegre
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	treatment
Enrollment	84
Start date	13 November 2019
Primary completion	1 July 2021
Estimated completion	1 July 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Chlorthalidone 25 mg — full drug profile →
• Hydrochlorothiazide 50 mg — full drug profile →
• Amiloride 20 mg — full drug profile →
• Amiloride 10 mg — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

Adults 30 to 75, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Mean change from baseline in 24-h systolic blood pressure measured by ABPM.
  Time frame: 12 weeks
  Difference between the treatment arms in mean change from baseline in 24-h systolic blood pressure measured by ABPM.
• Mean change from baseline in 24-h diastolic blood pressure measured by ABPM.
  Time frame: 12 weeks
  Difference between the treatment arms in mean change from baseline in 24-h diastolic blood pressure measured by ABPM.

Sponsor's own description

Thiazide diuretics have demonstrated favorable blood pressure lowering efficacy, safety profile and low cost, but it is still unclear what are the equivalence of doses of their more common agents, chlorthalidone and hydrochlorothiazide. Besides, concernments about adverse metabolic effects such as hypokalemia, hyperglycemia and hyperlipidemia do exist, which may be attenuated with the concomitant administration of a potassium-sparing diuretic, such as amiloride. In addition to control adverse effects of thiazides, amiloride could offer an additional blood pressure lowering effect, but the efficacy of different doses was not fully established. This study aims to investigate the blood pressure lowering efficacy of chlorthalidone and hydrochlorothiazide, in combination with amiloride in different doses, for the initial management in patients with primary hypertension.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Ecology of Antihypertensives in the United States, 1997-2017.
   Johansen ME, Niforatos JD, Sussman JB. · · 2021 · cited 8× · PMID 32968967 · DOI 10.1007/s11606-020-06214-1
2. Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial.
   Martins VM, Helal L, Ferrari F, Bottino LG, et al · · 2019 · cited 3× · PMID 31843024 · DOI 10.1186/s13063-019-3909-z