Monotherapy Versus Dual Therapy for Initial Treatment for Hypertension (Pathway 1)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Cambridge.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
University of Cambridge
Collaborator:
British Heart Foundation
Information provided by:
University of Cambridge
ClinicalTrials.gov Identifier:
NCT00994617
First received: October 13, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Resistant Hypertension |
Drug: Losartan and hydrochlorothiazide Drug: Hydrochlorothiazide switched over with Losartan at 8 weeks |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Monotherapy Versus Dual Therapy for Initial Treatment for Hypertension |
Resource links provided by NLM:
Further study details as provided by University of Cambridge:
Primary Outcome Measures:
- Change in mean home systolic BP for the group treated initially with monotherapy compared to the group treated initially with combination therapy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- A comparison the proportion of patients who drop out of the trial at any stage after randomisation or who require further antihypertensive treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 472 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
1 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 |
Drug: Losartan and hydrochlorothiazide
Losartan 50 -100mg Hydrochlorothiazide 12.5mg -25mg
|
|
Active Comparator: 2 arm
Initial monotherapy Hydrochlorothiazide 12.5mg -25mg Crossed over with Losartan 50 -100mg at 8 weeks
|
Drug: Hydrochlorothiazide switched over with Losartan at 8 weeks
Hydrochlorothiazide 12.5-25mg crossed over with Losartan 50-100mg
|
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.
- To determine if this 'never catch-up' phenomenon of improved BP control persists for at least one year.
To understand the underlying mechanism of improved BP control; specifically:
- To determine if it is due to haemodynamic compensation, such as increased sodium retention and volume expansion.
- To determine if it is due to increased peripheral resistance.
- To understand the predictors of BP control i.e. age, baseline renin status, sodium status and plasma volume.
- 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.
- To determine the safety and tolerability of a strategy of prescribing combination therapy as the initial step versus monotherapy as the initial step.
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Aged 18-79
- 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.
- BP >20/10 mmHg above SBP or DBP target (140/85 mmHg, or 130/80 mmHg if diabetic)
- Either never-treated or entry BP recorded (on ≥ 2 occasions) ≥ one month since receiving a maximum of one antihypertensive drug.
Exclusion Criteria:
- SBP > 200 mmHg or DBP > 120 mmHg
- Secondary or accelerated phase hypertension;
- eGFR < 60 mls/min;
- Contra-indication or previous intolerance to any trial therapy
- Failure to record required home BP readings during placebo run-in.
- Significant co-morbidity
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994617
Contacts
| Contact: Professor Morris Brown, FMedSCI | +44 (0)1223 336743 | mjb14@hermes.cam.ac.uk |
Locations
| United Kingdom | |
| Professor Morris Brown | Not yet recruiting |
| Cambridge, Cambridgeshire, United Kingdom, CB22QQ | |
| Contact: Jackie Salsbury, Nursing 01223 586878 js811@medschl.cam.ac.uk | |
Sponsors and Collaborators
University of Cambridge
British Heart Foundation
Investigators
| Principal Investigator: | Professor J Brown, FMedSci | University of Cambridge |
More Information
No publications provided
| Responsible Party: | Professor Morris Brown, Cambridge University |
| ClinicalTrials.gov Identifier: | NCT00994617 History of Changes |
| Other Study ID Numbers: | 2008-007749-29 |
| Study First Received: | October 13, 2009 |
| Last Updated: | October 13, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Hydrochlorothiazide Losartan Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |
Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013