HypertensionNCT00141583
The Renin-Angiotensin System in Essential Hypertension
A study testing Enalapril 20 mg bd and Candesartan 8 mg bd in people with Hypertension, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure lowering agents, the exact mechanisms by which these agents lower BP are still not fully understood. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Enalapril 20 mg bd and Candesartan 8 mg bd
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2004to Oct 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential Hypertension
- SBP 140-159 mmHg
- DBP 90-99 mmHg
Who cannot join
- Intolerance of or allergy to ACE Inhibitors or ARBS
- Pregnant or Breastfeeding
- Pre-menopausal women
- Uncontrolled cardiac or renal failure
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Blood Pressure Unit, Dept. Cardiac & Vascular Sciences, SGUL
London, SW17 0RE
About this study
Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure lowering agents, the exact mechanisms by which these agents lower BP are still not fully understood. This study aims to compare the blood pressure and hormonal responses (plasma renin activity and aldosterone) to the ACE inhibitor enalapril and ARB candesartan in individuals with mild essential hypertension.
- Conditions
- Hypertension
- Being tested
- Enalapril 20 mg bd, Candesartan 8 mg bd
- Keywords
- Renin-angiotensin system, ACE Inhibitor, Angiotensin Receptor Blocker
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enalapril 20 mg bdDrug
Candesartan 8 mg bdDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BP
Change in PRA and aldosterone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startApr 2004
- Study completionOct 2006
Why it stopped: Insufficient accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Investigators
- Timothy WR Doulton, BSc MRCP, Principal investigator, SGUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141583
- Sponsor's protocol ID
- LREC 01.87.10
- Status last verified
- May 2007
- First submitted
- 31 Aug 2005
- Last updated
- 9 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Renin-Angiotensin System in Essential Hypertension
- ClinicalTrials.gov ID
- NCT00141583
- Acronym / sponsor ID
- LREC 01.87.10
- Conditions
- Hypertension
- Keywords
- Renin-angiotensin system, ACE Inhibitor, Angiotensin Receptor Blocker
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual rate
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 1 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure lowering agents, the exact mechanisms by which these agents lower BP are still not fully understood. This study aims to compare the blood pressure and hormonal responses (plasma renin activity and aldosterone) to the ACE inhibitor enalapril and ARB candesartan in individuals with mild essential hypertension.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Essential Hypertension
- SBP 140-159 mmHg
- DBP 90-99 mmHg
Key exclusion criteria (5 listed)
- Intolerance of or allergy to ACE Inhibitors or ARBS
- Pregnant or Breastfeeding
- Pre-menopausal women
- Uncontrolled cardiac or renal failure
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enalapril 20 mg bd | Drug | – |
| Candesartan 8 mg bd | Drug | – |
Primary outcome
Change in BP
Change in PRA and aldosterone
Results and safety
The study was stopped early (reason given: Insufficient accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy WR Doulton, BSc MRCP principal investigator
SGUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enalapril 20 mg bd and Candesartan 8 mg bd in people with Hypertension, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BP. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015.