High Blood Pressure (Hypertension).Phase 3NCT00642096
Factorial Study of Metoprolol Succinate TOPROL-XL (324A)
A Phase 3 study testing Metoprolol Succinate and Hydrochlorothiazide in people with High Blood Pressure (Hypertension)., run by AstraZeneca.
Trial summary
The purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High Blood Pressure (Hypertension).
- What is being tested?
- Metoprolol Succinate and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Jul 2004
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diastolic blood pressure between 95 and 114 mm at screening and start of treatment
Who cannot join
- Significant conditions which in the opinion of the investigator place the subject at undue risk, eg Renal impairment, hepatitis
- Known secondary causes of hypertension, eg, Cushing's syndrome, renal artery stenosis, pheochromocytoma, hyperaldosteronism
- Systolic blood pressure greater or equal to 180 mm Hg at start of trial
About this study
Official title: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Factorial Study of Metoprolol Succinate Extended Release Tablets (TOPROL-XL) Hydrochlorothiazide and Their Combination in Patients With Essential Hypertension.
The purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. The study will also determine which combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering blood pressure (without unacceptable side effects), and whether it is possible to combine both drugs in a single tablet to simplify blood pressure treatment.
- Conditions
- High Blood Pressure (Hypertension).
- Being tested
- Metoprolol Succinate, Hydrochlorothiazide
- Keywords
- High blood pressure, hypertension, (TOPROL-XL), metoprolol succinate, hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol SuccinateDrug
Also called TOPROL-XL
HydrochlorothiazideDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Metoprolol Succinate + Hydrochlorothiazide Receives: Drug: Metoprolol Succinate; Drug: Hydrochlorothiazide |
| 2 | Active comparator | Metoprolol Succinate Receives: Drug: Metoprolol Succinate |
| 3 | Active comparator | Hydrochlorothiazide Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trough sitting diastolic blood pressure
Measured: 3 readings determined at 8 weeks after treatment
Secondary outcomes (3)
change in trough Sitting Systolic Blood pressure
Measured: 3 readings determined at 8 weeks after treatment
change in trough Standing Systolic Blood Pressure
Measured: 6 readings determined at 8 weeks after treatment
change in trough standing diastolic blood pressure
Measured: 6 readings determined at 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startJun 2003
- Primary completionJul 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood Pressure (Hypertension).Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Vasilios Papademetriou, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642096
- Sponsor's protocol ID
- D4026C00001
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2008
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Factorial Study of Metoprolol Succinate Extended Release Tablets (TOPROL-XL) Hydrochlorothiazide and Their Combination in Patients With Essential Hypertension.
- ClinicalTrials.gov ID
- NCT00642096
- Acronym / sponsor ID
- D4026C00001
- Conditions
- High Blood Pressure (Hypertension).
- Keywords
- High blood pressure, hypertension, (TOPROL-XL), metoprolol succinate, hydrochlorothiazide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 24 Mar 2008 (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.
The purpose of this research study is to determine if treatment with the combination of metoprolol succinate and hydrochlorothiazide is more effective at lowering blood pressure than treatment with either of the two drugs alone. The study will also determine which combined doses of metoprolol succinate and hydrochlorothiazide are most effective at lowering blood pressure (without unacceptable side effects), and whether it is possible to combine both drugs in a single tablet to simplify blood pressure treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Metoprolol Succinate, Drug: HydrochlorothiazideMetoprolol Succinate + Hydrochlorothiazide |
| 2 | Active comparator | Drug: Metoprolol SuccinateMetoprolol Succinate |
| 3 | Active comparator | Drug: HydrochlorothiazideHydrochlorothiazide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diastolic blood pressure between 95 and 114 mm at screening and start of treatment
Key exclusion criteria (3 listed)
- Significant conditions which in the opinion of the investigator place the subject at undue risk, eg Renal impairment, hepatitis
- Known secondary causes of hypertension, eg, Cushing's syndrome, renal artery stenosis, pheochromocytoma, hyperaldosteronism
- Systolic blood pressure greater or equal to 180 mm Hg at start of trial
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 |
|---|---|---|
| Metoprolol SuccinateAlso: TOPROL-XL | Drug | 1, 2 |
| Hydrochlorothiazide | Drug | 1, 3 |
Primary outcome
Change in trough sitting diastolic blood pressure
Time frame: 3 readings determined at 8 weeks after treatment
3 secondary outcomes
change in trough Sitting Systolic Blood pressure
Time frame: 3 readings determined at 8 weeks after treatment
change in trough Standing Systolic Blood Pressure
Time frame: 6 readings determined at 8 weeks after treatment
change in trough standing diastolic blood pressure
Time frame: 6 readings determined at 8 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2009.
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.
Vasilios Papademetriou principal investigator
Georgetown University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metoprolol Succinate and Hydrochlorothiazide in people with High Blood Pressure (Hypertension)., run by AstraZeneca.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 25 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 trough sitting diastolic blood pressure (time frame: 3 readings determined at 8 weeks after treatment). 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 25 Mar 2009.