Essential HypertensionNCT00380289
Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension
A study testing Thiazide and beta blocker in people with Essential Hypertension, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two? Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Thiazide and beta blocker
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2006to not given
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers will be aged 18-75 years.
- Hypertension- either
- untreated, BP 140-170/90-110
- treated for over 1 month with drugs other than beta blockers or diuretic and BP>140/85
- treated for over 1 month with drugs other than beta blockers or diuretic and BP<140/85 and patient willing to change medication for eight months.
Who cannot join
- Any patient already taking thiazide diuretics or beta blockers in whom these drugs cannot be switched to alternative drugs with similar or better blood pressure control.
- Any patient who is intolerant of these medications will be excluded from the study.
- Patients with gout, asthma or any other contraindications to the study drugs will be excluded.
- Women of child bearing age not using contraception.
- Volunteers with heart failure, liver failure, renal failure, terminal illnesses (e.g. cancer)
- Volunteers not able to give informed consent
- Patients with diabetes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Pharmacology Unit, Box 110, Level 3 ACCI, Addenbrookes Hospital
Cambridge, CB2 2QQ
Mrs M Watts, 01223 586865, mw363@medschl.cam.ac.uk
Dr A Stears, MBBS BSc MRCP, 01223 586878, as659@medschl.cam.ac.uk
About this study
Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two?
Read the detailed description
We will be comparing the two most commonly used drugs to treat hypertension, atenolol and bendrofluazide, in patients for whom the drugs (and the doses to be used) are licenced.
We propose an initial open label pilot study of 10-12 patients to confirm final doses to be tested, the duration of therapy for optimum timing of the OGTT and tolerability of doses selected. The pilot study will also be used to confirm sample size calculations for the main study.The protocol for the pilot study will be identical to the main study, but there will not be a placebo phase and the treatment will not be blinded.
The main study will be double-blind, placebo controlled, cross-over study, of approximately 66 patients in which each patient receives in random order, 4 weeks treatment with either Bendrofluazide 5-10mg daily, Atenolol 50-100mg daily or combination of Bendrofluazide 2.5-5mg and Atenolol 25-50mg daily. There will be a forced titration from the lower to the higher dose stated half way through each dosing period. There will be a 1 month placebo wash-out between each dosing period.
At 0, 2 and 4 weeks of each treatment phase, patients will attend the Clinical Investigation Ward (CIW), fasting, for performance of an oral glucose tolerance test (OGTT). Blood will be drawn from an intravenous cannula, for the measurements of glucose and insulin at 0, 0.5, 1 and 2 hours.
Blood pressure will be measured at each study visit using an Omron machine. The patients will also be given a blood pressure machine to take home and will be asked to measure and record their blood pressure at least twice per week. If their blood pressure is under 110/70mmhg or over 160/110mmHg at any time or if the patient has symptoms e.g. headache or dizziness, the patient will be asked to contact study staff. If the blood pressure remains over 160/110 for two measurements, then another antihypertensive therapy may be commenced, or the patient withdrawn from the study. If blood pressure is < 110/70 mmHg with symptoms then a decision may be made to terminate their participation in the study.
- Conditions
- Essential Hypertension
- Being tested
- Thiazide and beta blocker
- Keywords
- Essential hypertension, Glucose metabolism, Thiazides, Beta blockers
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiazide and beta blockerDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two?
Secondary outcomes (2)
Do patients show a similar change in glucose tolerance after thiazide or beta blocker therapy?
Does the combination of drugs cause a greater reduction in glucose tolerance than expected from the response to each drug taken alone?
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Professor MJ Brown, MA MSC MD FRCP, Principal investigator, Addenbrookes Hosptal NHS Trust/ University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380289
- Sponsor's protocol ID
- OGTT1
- Status last verified
- Sep 2006
- First submitted
- 22 Sep 2006
- Last updated
- 25 Sep 2006
- Results posted
- No
Publications
Stears AJ, Woods SH, Watts MM, Burton TJ, Graggaber J, Mir FA, Brown MJ. A double-blind, placebo-controlled, crossover trial comparing the effects of amiloride and hydrochlorothiazide on glucose tolerance in patients with essential hypertension. Hypertension. 2012 May;59(5):934-42. doi: 10.1161/HYPERTENSIONAHA.111.189381. Epub 2012 Apr 9.
PubMed 22493073
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension
- ClinicalTrials.gov ID
- NCT00380289
- Acronym / sponsor ID
- OGTT1
- Conditions
- Essential Hypertension
- Keywords
- Essential hypertension, Glucose metabolism, Thiazides, Beta blockers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust
- Study start
- Sep 2006
- First posted
- 25 Sep 2006 (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.
Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two?
Detailed description
We will be comparing the two most commonly used drugs to treat hypertension, atenolol and bendrofluazide, in patients for whom the drugs (and the doses to be used) are licenced.
We propose an initial open label pilot study of 10-12 patients to confirm final doses to be tested, the duration of therapy for optimum timing of the OGTT and tolerability of doses selected. The pilot study will also be used to confirm sample size calculations for the main study.The protocol for the pilot study will be identical to the main study, but there will not be a placebo phase and the treatment will not be blinded.
The main study will be double-blind, placebo controlled, cross-over study, of approximately 66 patients in which each patient receives in random order, 4 weeks treatment with either Bendrofluazide 5-10mg daily, Atenolol 50-100mg daily or combination of Bendrofluazide 2.5-5mg and Atenolol 25-50mg daily. There will be a forced titration from the lower to the higher dose stated half way through each dosing period. There will be a 1 month placebo wash-out between each dosing period.
At 0, 2 and 4 weeks of each treatment phase, patients will attend the Clinical Investigation Ward (CIW), fasting, for performance of an oral glucose tolerance test (OGTT). Blood will be drawn from an intravenous cannula, for the measurements of glucose and insulin at 0, 0.5, 1 and 2 hours.
Blood pressure will be measured at each study visit using an Omron machine. The patients will also be given a blood pressure machine to take home and will be asked to measure and record their blood pressure at least twice per week. If their blood pressure is under 110/70mmhg or over 160/110mmHg at any time or if the patient has symptoms e.g. headache or dizziness, the patient will be asked to contact study staff. If the blood pressure remains over 160/110 for two measurements, then another antihypertensive therapy may be commenced, or the patient withdrawn from the study. If blood pressure is < 110/70 mmHg with symptoms then a decision may be made to terminate their participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Volunteers will be aged 18-75 years.
- Hypertension- either
Key exclusion criteria (7 listed)
- Any patient already taking thiazide diuretics or beta blockers in whom these drugs cannot be switched to alternative drugs with similar or better blood pressure control.
- Any patient who is intolerant of these medications will be excluded from the study.
- Patients with gout, asthma or any other contraindications to the study drugs will be excluded.
- Women of child bearing age not using contraception.
- Volunteers with heart failure, liver failure, renal failure, terminal illnesses (e.g. cancer)
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 |
|---|---|---|
| Thiazide and beta blocker | Drug | – |
Primary outcome
Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two?
2 secondary outcomes
Do patients show a similar change in glucose tolerance after thiazide or beta blocker therapy?
Does the combination of drugs cause a greater reduction in glucose tolerance than expected from the response to each drug taken alone?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2006.
- Derived from this study: PubMed 22493073Stears AJ, Woods SH, Watts MM, Burton TJ, Graggaber J, Mir FA, Brown MJ. A double-blind, placebo-controlled, crossover trial comparing the effects of amiloride and hydrochlorothiazide on glucose tolerance in patients with essential hypertension. Hypertension. 2012 May;59(5):934-42. doi: 10.1161/HYPERTENSIONAHA.111.189381. Epub 2012 Apr 9.
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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.
Professor MJ Brown, MA MSC MD FRCP principal investigator
Addenbrookes Hosptal NHS Trust/ University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thiazide and beta blocker in people with Essential Hypertension, run by University of Cambridge 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Sep 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Professor MJ Brown, MA MSC MD FRCP (01223 762577 (UK), mjb14@medschl.cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two?. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00380289, which also lists 1 linked publication.
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 25 Sep 2006.