Comparison of Single and Combination Diuretics in Low-Renin Hypertension

Summary

The purpose of this study is to determine whether the routine combination of optimal thiazide and K+-sparing diuretic will both increase efficacy of BP reduction and reduce risk of glucose intolerance; and whether K+-sparing diuretics alone may have a neutral or even beneficial effect upon glucose tolerance.

Conditions

• Hypertension

Interventions

DRUG

Hydrochlorthiazide

HCTZ 25mg to 50mg All drugs will be provided in an acceptable container where the active agent is not identified on the drug label. In Phase 1 (weeks 0-12) patients will have 1 tablet from each of 2 bottles. These will contain either a) HCTZ 12.5mg in both bottles; b) amiloride 5mg in both bottles; OR c) one bottle of each. In Phase 2 (weeks13-24) patients will take 2 tablets from each of 2 bottles. These bottles will have the same contents as in Phase 1, except that the number of tablets will be twice as many.

DRUG

Amiloride

Amiloride 10mg to 20mg All drugs will be provided in an acceptable container where the active agent is not identified on the drug label. In Phase 1 (weeks 0-12) patients will have 1 tablet from each of 2 bottles. These will contain either a) HCTZ 12.5mg in both bottles; b) amiloride 5mg in both bottles; OR c) one bottle of each. In Phase 2 (weeks13-24) patients will take 2 tablets from each of 2 bottles. These bottles will have the same contents as in Phase 1, except that the number of tablets will be twice as many.

DRUG

Hydrochlorthiazide and Amiloride

HCTZ 12.5 to 25mg \& + Amiloride 5mg to 10mg All drugs will be provided in an acceptable container where the active agent is not identified on the drug label. In Phase 1 (weeks 0-12) patients will have 1 tablet from each of 2 bottles. These will contain either a) HCTZ 12.5mg in both bottles; b) amiloride 5mg in both bottles; OR c) one bottle of each. In Phase 2 (weeks13-24) patients will take 2 tablets from each of 2 bottles. These bottles will have the same contents as in Phase 1, except that the number of tablets will be twice as many.

Sponsors & Collaborators

• University of Leicester

  collaborator OTHER

• University of Dundee

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• King's College London

  collaborator OTHER

• University of Birmingham

  collaborator OTHER

• University of Cambridge

  lead OTHER

Principal Investigators

• Professor MJ Brown · Cambridge University and Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2015-07-31

Completion

2015-08-31

Countries

• United Kingdom

Study Locations