HypertensionPhase 4NCT00129909
STITCH (Simplified Therapeutic Intervention To Control Hypertension)
A Phase 4 study testing fixed dose combination therapy in people with Hypertension, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
The objective of this study is to assess whether the implementation of a primary treatment algorithm using a fixed dose combination therapy will improve the management of hypertension when compared to usual management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- fixed dose combination therapy
- How many people
- 2,081 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Jan 2007
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years or older
- Hypertension SBP ≥ 140 mmHg or DBP ≥ 90 mmHg whether untreated or partially treated
- Absence of ischemic heart disease, atrial fibrillation, peripheral vascular disease, stroke and chronic kidney disease
- Not participating in other hypertension studies
- Ability to give informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Primary Treatment Algorithm Using Fixed Dose Combination Therapy for the Management of Hypertension - Control and Intervention Arms
The objective of this study is to assess whether the implementation of a primary treatment algorithm using a fixed dose combination therapy will improve the management of hypertension when compared to usual management.
Read the detailed description
There is a clear need for improved approaches for both improved blood pressure control and improved compliance with medication regimens. Although decreasing the frequency of drug taking does improve blood pressure control, whether fixed-dose combinations are more effective than taking multiple tablets is unknown. Additionally, notwithstanding the presence of excellent evidence-based recommendations for the treatment of hypertension, the choices for practitioners in regards to first line therapy is widening (and may be more confusing, especially in the setting of the proliferation of recommendations for a range of diseases). Whether a simplified treatment algorithm, consistent with the Canadian Hypertension Education Program (CHEP) guidelines but using a step-care approach, might improve management of hypertension is unknown. The current study will determine the effectiveness of a simplified treatment algorithm which incorporates early use of a fixed-dose combination therapy.
This is a cluster randomized controlled trial. Approximately 50 family practices eligible for study participation will be randomized in a 1:1 ratio to implement a treatment algorithm or to continue usual care for the management of hypertension. The randomization schedule will be stratified by the year of graduation of the family physician (< 1984 or ≥ 1984). Within each practice, 50 subjects will be managed according to the algorithm or usual care and will be followed for six months.
- Conditions
- Hypertension
- Being tested
- fixed dose combination therapy
- Keywords
- hypertension, family physicians, fixed dose combination therapy, cluster randomized controlled trial
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixed dose combination therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary measure of outcome is the proportion of subjects treated to target (systolic blood pressure [SBP] <140 mmHg and diastolic blood pressure [DBP] <90 mmHg) at 6 months, compared at the practice level.
Secondary outcomes (2)
Secondary measures of response will include the change at 6 months in systolic blood pressure and diastolic blood pressure. These outcomes will be compared at the practice level
Provider satisfaction will be obtained by means of a questionnaire administered at each practice after the last study participant completes the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startMay 2005
- Primary completionSep 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Ross D Feldman, MD, Study director, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129909
- Sponsor's protocol ID
- RPO402A; RPO402B
- Status last verified
- Jun 2012
- First submitted
- 10 Aug 2005
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirkland SA, MacLean DR, Langille DB, Joffres MR, MacPherson KM, Andreou P. Knowledge and awareness of risk factors for cardiovascular disease among Canadians 55 to 74 years of age: results from the Canadian Heart Health Surveys, 1986-1992. CMAJ. 1999;161(8 Suppl):S10-6.
PubMed 10551207Berlowitz DR, Ash AS, Hickey EC, Friedman RH, Glickman M, Kader B, Moskowitz MA. Inadequate management of blood pressure in a hypertensive population. N Engl J Med. 1998 Dec 31;339(27):1957-63. doi: 10.1056/NEJM199812313392701.
PubMed 9869666Khan NA, McAlister FA, Campbell NR, Feldman RD, Rabkin S, Mahon J, Lewanczuk R, Zarnke KB, Hemmelgarn B, Lebel M, Levine M, Herbert C; Canadian Hypertension Education Program. The 2004 Canadian recommendations for the management of hypertension: Part II--Therapy. Can J Cardiol. 2004 Jan;20(1):41-54.
PubMed 14968142ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97. doi: 10.1001/jama.288.23.2981.
PubMed 12479763
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Primary Treatment Algorithm Using Fixed Dose Combination Therapy for the Management of Hypertension - Control and Intervention Arms
- ClinicalTrials.gov ID
- NCT00129909
- Acronym / sponsor ID
- RPO402A; RPO402B
- Conditions
- Hypertension
- Keywords
- hypertension, family physicians, fixed dose combination therapy, cluster randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,081 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 12 Aug 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.
The objective of this study is to assess whether the implementation of a primary treatment algorithm using a fixed dose combination therapy will improve the management of hypertension when compared to usual management.
Detailed description
There is a clear need for improved approaches for both improved blood pressure control and improved compliance with medication regimens. Although decreasing the frequency of drug taking does improve blood pressure control, whether fixed-dose combinations are more effective than taking multiple tablets is unknown. Additionally, notwithstanding the presence of excellent evidence-based recommendations for the treatment of hypertension, the choices for practitioners in regards to first line therapy is widening (and may be more confusing, especially in the setting of the proliferation of recommendations for a range of diseases). Whether a simplified treatment algorithm, consistent with the Canadian Hypertension Education Program (CHEP) guidelines but using a step-care approach, might improve management of hypertension is unknown. The current study will determine the effectiveness of a simplified treatment algorithm which incorporates early use of a fixed-dose combination therapy.
This is a cluster randomized controlled trial. Approximately 50 family practices eligible for study participation will be randomized in a 1:1 ratio to implement a treatment algorithm or to continue usual care for the management of hypertension. The randomization schedule will be stratified by the year of graduation of the family physician (< 1984 or ≥ 1984). Within each practice, 50 subjects will be managed according to the algorithm or usual care and will be followed for six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects 18 years or older
- Hypertension SBP ≥ 140 mmHg or DBP ≥ 90 mmHg whether untreated or partially treated
- Absence of ischemic heart disease, atrial fibrillation, peripheral vascular disease, stroke and chronic kidney disease
- Not participating in other hypertension studies
- Ability to give informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| fixed dose combination therapy | Drug | – |
Primary outcome
The primary measure of outcome is the proportion of subjects treated to target (systolic blood pressure [SBP] <140 mmHg and diastolic blood pressure [DBP] <90 mmHg) at 6 months, compared at the practice level.
2 secondary outcomes
Secondary measures of response will include the change at 6 months in systolic blood pressure and diastolic blood pressure. These outcomes will be compared at the practice level
Provider satisfaction will be obtained by means of a questionnaire administered at each practice after the last study participant completes the study.
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 14 Jun 2012.
- Background: PubMed 10551207Kirkland SA, MacLean DR, Langille DB, Joffres MR, MacPherson KM, Andreou P. Knowledge and awareness of risk factors for cardiovascular disease among Canadians 55 to 74 years of age: results from the Canadian Heart Health Surveys, 1986-1992. CMAJ. 1999;161(8 Suppl):S10-6.
- Background: PubMed 9869666Berlowitz DR, Ash AS, Hickey EC, Friedman RH, Glickman M, Kader B, Moskowitz MA. Inadequate management of blood pressure in a hypertensive population. N Engl J Med. 1998 Dec 31;339(27):1957-63. doi: 10.1056/NEJM199812313392701.
- Background: PubMed 14968142Khan NA, McAlister FA, Campbell NR, Feldman RD, Rabkin S, Mahon J, Lewanczuk R, Zarnke KB, Hemmelgarn B, Lebel M, Levine M, Herbert C; Canadian Hypertension Education Program. The 2004 Canadian recommendations for the management of hypertension: Part II--Therapy. Can J Cardiol. 2004 Jan;20(1):41-54.
- Background: PubMed 12479763ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97. doi: 10.1001/jama.288.23.2981.
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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.
Ross D Feldman, MD study director
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fixed dose combination therapy in people with Hypertension, run by University of Western Ontario, Canada at 1 site in Canada.
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 0 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 14 Jun 2012. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary measure of outcome is the proportion of subjects treated to target (systolic blood pressure [SBP] <140 mmHg and diastolic blood pressure [DBP] <90 mmHg) at 6 months, compared at the practice level.. 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 NCT00129909, which also lists 4 linked publications.
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 14 Jun 2012.