Tolerability of different doses of blood pressure lowering Polypill

Phase 3

• Conditions: Systemic hypertension; Complicated hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12618001625268
• Lead Sponsor: Beyond Community & Health Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-03
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

To qualify, patients must have:

ECG changes typical of hypertension: T-wave flattening or inversion, and/or voltage LVH and/or left axis deviation.

Previous SBP between 150 and 200 mm Hg systolic

Exclusion Criteria

No clinical cardiovascular events (angina, acute coronary syndrome/AMI, cardiac failure, TIA or stroke) in the previous 1 year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events<br>eg faintness, syncope, rash, nausea<br><br>Any intolerance and all specific adverse symptoms will be evaluated every 3 weeks, in the clinic and by telephone.<br>All new or increased symptoms will be documented and evaluated as possible adverse events.<br><br><br>[3 Phases, each of 9 weeks duration<br><br>Baseline (commencement of Phase 1 of drug treatment)<br>9 weeks post-commencement = beginning of Phase 2<br>18 weeks = beginning of Phase 3 <br>Finish at 27 weeks<br><br><br>]

Secondary Outcome Measures

Name	Time	Method
Mean blood pressure (clinic, ambulatory)<br><br>[At baseline and at 6 & 9 weeks in each of the 3 Phases, clinic and 24 hour ambulatory BP & HR];Mean heart rate (ECG, clinic, ambulatory)[At baseline and at 6 & 9 weeks in each of the 3 Phases, ECG, clinic and 24 hour ambulatory HR]