NCT02641652

A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension (ATRAX Trial)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: University Hospital Olomouc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is currently no established treatment for paroxysmal hypertension, but selective serotonin reuptake inhibitors showed good effect in previous reports. This double-blind, placebo controlled, prospective multicenter clinical trial will assess the efficacy of sertraline on cessation or reduction of symptoms of paroxysmal arterial hypertension. 136 patients with documented hypertensive paroxysms with abrupt elevations of blood pressure and distressful physical symptoms will be randomized in a 1:1 ratio to receive sertraline, 50 mg daily, or matching placebo as an add-on to their chronic medication. Effect of the treatment on patient symptoms, office and ambulatory blood pressure and side effects will be evaluated after 3 months. If proven effective, sertraline might become a standard treatment for this condition.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Sertraline	25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial
DRUG	Placebo	1/2 tablet once daily for first 7 days, then 1 tablet once daily for the rest of the trial

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2015-12-29
• Last updated: 2017-09-08

Regulatory

• FDA-regulated drug study