NCT00994617

Monotherapy Versus Dual Therapy for Initial Treatment for Hypertension

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Cambridge · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

To test whether the current custom of initiating treatment for hypertension with a single drug is less effective in the short-term than initial combination therapy, and results in the eventual need for comparatively more antihypertensive drug therapy.

Detailed description

To determine if patients randomised to more aggressive (combination therapy) treatment for the initial treatment of hypertension have better blood pressure control compared to those randomised to less aggressive (monotherapy) treatment despite subsequent add-on treatment being similar in each group. This will test the hypothesis that monotherapy patients 'never catch up' with combination therapy patients. 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

• Hypertension, Resistant to Conventional Therapy
• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Losartan and hydrochlorothiazide	Losartan 50 -100mg Hydrochlorothiazide 12.5mg -25mg
DRUG	Hydrochlorothiazide switched over with Losartan at 8 weeks	Hydrochlorothiazide 12.5-25mg crossed over with Losartan 50-100mg

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2009-10-14
• Last updated: 2013-06-12

Locations

13 sites across 1 country: United Kingdom