Quadruple UltrA-low-dose tReaTment for hypErTension - QUARTET

Phase 3

Completed

• Conditions: Hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12616001144404
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-23
• Study Completion: 2020-11-23
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 591

Inclusion Criteria

•Adults (=18 years)
•Previous documentation of hypertension or high blood pressure (SBP 140-179mmHg and/or DBP 90-109 mmHg) from GP, pharmacist or health care professional
•And either meeting criteria A or B
-Criteria A: In treatment naïve (i.e. never treated) or in patients currently not on treatment (not taken in last 4 weeks) either:
•A measure of Clinic SBP 140-179mmHg and/or DBP 90-109 mmHg
documented by study staff in the last 12 weeks with a study automatic BP
device OR
•A recorded measure of daytime average SBP = 135 mmHg and/or DBP = 85
mmHg on a 24 hour ambulatory BP monitoring device in the last 12 weeks
-Criteria B: In patients currently taking one BP lowering drug ‘monotherapy’ (i.e. ACE-I, ARB, CCB, BB, aldosterone antagonist, alpha-blocker) either:
•A measure of Clinic SBP 130-179mmHg and/or DBP 85-109 mmHg
documented by study staff in the last 12 weeks with a study automatic BP
device OR
•A recorded measure of daytime average SBP = 125 mmHg and/or DBP = 80
mmHg on a 24 hour ambulatory BP monitoring device in the last 12 weeks

Exclusion Criteria

* Contraindication to irbesartan, amlodipine, indapamide or bisoprolol
* Evidence of secondary cause of hypertension e.g. renal artery stenosis; Significant renal impairment (eGRF <50), raised serum potassium (above lab normal limit)
* Women who are pregnant, breast feeding and/ or of childbearing potential and not using effective contraception throughout the study (pharmacological or barrier methods)
* Concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary care physician could interfere with the conduct of the study including outcome assessments
* Participation in a concurrent interventional medical investigation or clinical trial. Patients in observational, natural history and/or epidemiological studies not involving an intervention are eligible.
* Participants responsible primary care or other responsible physician believes it is not appropriate for participant to switch current monotherapy
* Inability or unwillingness to provide written informed consent
* Unable to complete study procedures including 24 hour ambulatory blood pressure
* Definite indication for combination therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be difference between groups in mean automated office systolic blood pressure adjusted for baseline values[12 weeks ]

Secondary Outcome Measures

Name	Time	Method
Difference between groups in mean 24-hour ambulatory systolic blood pressure measured using automated sphygmomanometry[24 hours at each of 12 weeks and 52 weeks];Difference between groups in mean automated office diastolic blood pressure[12 and 52 weeks];Hypertension control (% with SBP <140 mmHg and DBP <90 mmHg) using automated office sphygmomanometry[6, 12, 52 weeks ];Difference between groups in mean 24-hour ambulatory diastolic blood pressure measured using automated sphygmomanometry[24 hours at each of 12 weeks and 52 weeks];Difference between groups in mean automated office systolic blood pressure[52 weeks]