Monotherapy Versus Dual Therapy for Initial Treatment for Hypertension
NCT ID: NCT00994617
Last Updated: 2013-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
600 participants
INTERVENTIONAL
2010-01-31
2014-12-31
Brief Summary
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Detailed Description
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1. To determine if this 'never catch-up' phenomenon of improved BP control persists for at least one year.
2. To understand the underlying mechanism of improved BP control; specifically:
1. To determine if it is due to haemodynamic compensation, such as increased sodium retention and volume expansion.
2. To determine if it is due to increased peripheral resistance.
3. To understand the predictors of BP control i.e. age, baseline renin status, sodium status and plasma volume.
4. To validate the National Institute for Clinical Excellence / British Hypertension Society joint guideline ACD algorithm by comparing BP control in the monotherapy crossover arm of phase 1 and to correlate this with age (≤ 55 or \> 55y), and baseline characteristics such as renin.
5. To determine the safety and tolerability of a strategy of prescribing combination therapy as the initial step versus monotherapy as the initial step.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Combination Therapy
Patients treated with combination therapy of Hydrochlorthiazide plus Losartan. Losartan will be force-titrated from 50 to 100mg, Hydrochlorothiazide will be force-titrated from 12.5mg to 25mg
Losartan and hydrochlorothiazide
Losartan 50 -100mg Hydrochlorothiazide 12.5mg -25mg
Monotherapy
Initial monotherapy Hydrochlorothiazide 12.5mg -25mg Crossed over with Losartan 50 -100mg at 8 weeks
Hydrochlorothiazide switched over with Losartan at 8 weeks
Hydrochlorothiazide 12.5-25mg crossed over with Losartan 50-100mg
Interventions
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Losartan and hydrochlorothiazide
Losartan 50 -100mg Hydrochlorothiazide 12.5mg -25mg
Hydrochlorothiazide switched over with Losartan at 8 weeks
Hydrochlorothiazide 12.5-25mg crossed over with Losartan 50-100mg
Eligibility Criteria
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Inclusion Criteria
2. Male subjects or female subjects taking adequate contraception such as the oral contraceptive pill, an intra uterine device or who are surgically sterilised or postmenopausal Females
3. BP ≥150 mmHg (systolic) OR ≥ 95 mmHg (diastolic). Patients may be included if the PI anticipates BP criteria for inclusion will be met at randomisation
4. Either never-treated or received a maximum of one antihypertensive drug class in the previous year
Patients will be excluded for ANY ONE of the following reasons
1. Clinic SBP \> 200 mmHg or DBP \> 120 mmHg, with PI discretion to override if home BP measurements are lower
2. Secondary or accelerated phase hypertension
3. eGFR \< 45 mls/min
4. Contra-indication or previous intolerance to any trial therapy
5. Failure to record required home BP readings during placebo run-in.
6. Significant co-morbidity (investigator opinion but to include alcoholism, terminal illness, documented non-attendance at clinics etc)
7. Diabetes type 1
8. Plasma K+ outside normal range on two successive measurements during screening
9. Requirement for treatment with ≥2 drugs (which can be a CCB and/or {ACEi OR ARB OR direct renin inhibitor OR β-blocker}) in order to reduce blood pressure to ≤180/120 mmHg
10. Requirement for diuretic therapy (other than for hypertension)
11. Requirement for ACE inhibitor (or ARB) therapy (other than for hypertension)
12. Absolute contra-indications to any of the study drugs (listed on their data-sheet)
13. Current therapy for cancer
14. Anticipation of change in medical status during course of trial (e.g. planned surgical intervention requiring \>2 weeks convalescence , actual or planned pregnancy)
15. Inability to give informed consent
16. Participation in a clinical study involving an investigational drug or device within 4 weeks of screening.
17. Any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or severely limit the subject's lifespan or ability to complete the study (eg, alcohol or drug abuse, disabling or terminal illness, mental disorders).
18. Treatment with any of the following prohibited medications:
1. Oral corticosteroids within 3 months of screening. Treatment with systemic corticosteroids is also prohibited during study participation.
Chronic stable or unstable use of non-steroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid is prohibited. Chronic use is defined as \>3 consecutive or nonconsecutive days of treatment per week. In addition, the intermittent use of NSAIDs is strongly discouraged throughout the duration of this study. If intermittent treatment is required, NSAIDs must not be used for more than a total of 2 days. For all subjects requiring analgesic or anti-pyretic agents, the use of paracetamol is recommended during study participation.
2. The use of short-acting oral nitrates (eg, sublingual nitroglycerin) is permitted; however, subjects should not take short-acting oral nitrates within 4 hours of screening or any subsequent study visit.
3. The use of long-acting oral nitrates (eg, Isordil) is permitted; however, the dose must be stable for at least 2 weeks prior to screening and randomisation.
4. The use of sympathomimetic decongestants is permitted; however, not within 1 day prior to any clinic visit/BP assessment.
5. The use of theophylline is permitted; however, the dose must be stable for at least 4 weeks prior to screening and throughout study participation.
6. The use of phosphodiesterase (PDE) type V inhibitors is permitted; however, subjects must refrain from taking these medications within 1 day of screening or any subsequent study visit.
7. The use of alpha-blockers is not permitted - with the exception of afluzosin and tamsulosin for prostatic symptoms
18 Years
79 Years
ALL
No
Sponsors
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British Heart Foundation
OTHER
University of Cambridge
OTHER
Responsible Party
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Morris Brown
Prof Morris Brown
Principal Investigators
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Professor MJ Brown, FMedSci
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge
Locations
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Professor Morris Brown
Cambridge, Cambridgeshire, United Kingdom
NHS Ayrshire
Ayrshire, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
NHS Tayside/University of Dundee
Dundee, , United Kingdom
NHS Lothian/University of Edinburgh
Edinburgh, , United Kingdom
NHS Greater Glasgow and Clyde/University of Glasgow
Glasgow, , United Kingdom
Ixworth GP Practice
Ixworth, , United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Barts and the London School of Medicine and Dentistry
London, , United Kingdom
Guys and St Thomas' NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust
Manchester, , United Kingdom
Norfolk and Norwich University Hospital NHS Trust
Norwich, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Prof M Caulfield
Role: primary
References
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MacDonald TM, Williams B, Webb DJ, Morant S, Caulfield M, Cruickshank JK, Ford I, Sever P, Mackenzie IS, Padmanabhan S, McCann GP, Salsbury J, McInnes G, Brown MJ; British Hypertension Society Programme of Prevention And Treatment of Hypertension With Algorithm-based Therapy (PATHWAY). Combination Therapy Is Superior to Sequential Monotherapy for the Initial Treatment of Hypertension: A Double-Blind Randomized Controlled Trial. J Am Heart Assoc. 2017 Nov 18;6(11):e006986. doi: 10.1161/JAHA.117.006986.
Other Identifiers
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2008-007749-29
Identifier Type: -
Identifier Source: org_study_id
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