HypertensionPhase 4NCT00313547
High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients
A Phase 4 study testing Quinapril 40 mg and Quinapril 10 mg and amlodipine 5 mg in people with Hypertension, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
The purpose of this study is to compare the impact of two blood pressure lowering treatments (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate over 24 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Quinapril 40 mg and Quinapril 10 mg and amlodipine 5 mg
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Mar 2008
- 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
- Patients with a documented history of hypertension defined as: SBP > or = 140 mmHg or DBP > or = 90 mmHg if hypertension untreated or patients currently treated for hypertension.
- Documented CAD or diabetes or impaired glucose tolerance
- Sinus rhythm
- Principal Exclusion Criteria:
- Previous intolerance or allergic reaction to an ACE inhibitor, an ARB or dihydropyridine calcium channel blocker
- History of angioedema or cough related to previous ACE inhibitor use.
Show all 18Show fewer
- Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg in untreated patients
- Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg in patients currently treated by an ACE inhibitor or an ARB
- Creatinine clearance < 30 ml/min
- Significant liver dysfunction
- Current serum potassium > or = 5 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia resulting in either a serum potassium > or = 5.5 mmol/L or a life-threatening adverse event.
- History of HF or known LVEF < or = 45%
- Bilateral renal artery stenosis (or unilateral if only one kidney)
- Unstable angina, myocardial infarction or coronary revascularization within the last 3 months.
- Connective tissue disease or chronic inflammatory condition
- Active malignancy
- Active infection in the last 2 weeks
- Inability or any contraindication to perform an exercise test.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine on Autonomic Regulation and on Sympathetic Activation in Response to Cold Exposure in Hypertensive Patients With Impaired Glucose Tolerance, Diabetes or Coronary Artery Disease
The purpose of this study is to compare the impact of two blood pressure lowering treatments (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate over 24 hours.
- Conditions
- Hypertension
- Being tested
- Quinapril 40 mg, Quinapril 10 mg and amlodipine 5 mg
- Keywords
- Blood pressure, Hypertension, Renin, Aldosterone, Heart rate variability
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinapril 40 mgDrug
Quinapril 10 mg and amlodipine 5 mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Secondary outcomes (9)
Tolerability
Renin, aldosterone
MMPs
Oxidative stress
Norepinephrine
Lactate
Exercise tolerance at 20 and -8 degree celsius
Blood pressure
Impact of selected pharmacogenetic polymorphisms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2007
- Study completionMar 2008
Why it stopped: Very difficult to recruit patients/slow recruitment(2 patients in nearly 2 years).
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Michel White, MD, Principal investigator, Montreal Heart InstituteSimon de Denus, B. Pharm, MSc, Principal investigator, Faculty of Pharmacy, University of Montreal/Montreal Heart InstituteJacques de Champlain, MD, PhD, Principal investigator, Faculty of Medicine, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313547
- Sponsor's protocol ID
- MHI 05740
- Other IDs
- Pfizer NRA9060008, (Investigator initiated study)
- Status last verified
- Aug 2007
- First submitted
- 10 Apr 2006
- Last updated
- 6 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine on Autonomic Regulation and on Sympathetic Activation in Response to Cold Exposure in Hypertensive Patients With Impaired Glucose Tolerance, Diabetes or Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00313547
- Acronym / sponsor ID
- MHI 05740
- Conditions
- Hypertension
- Keywords
- Blood pressure, Hypertension, Renin, Aldosterone, Heart rate variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very difficult to recruit patients/slow recruitment(2 patients in nearly 2 years).
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Apr 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.
The purpose of this study is to compare the impact of two blood pressure lowering treatments (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate over 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 (18 listed)
- Patients with a documented history of hypertension defined as: SBP > or = 140 mmHg or DBP > or = 90 mmHg if hypertension untreated or patients currently treated for hypertension.
- Documented CAD or diabetes or impaired glucose tolerance
- Sinus rhythm
- Previous intolerance or allergic reaction to an ACE inhibitor, an ARB or dihydropyridine calcium channel blocker
- History of angioedema or cough related to previous ACE inhibitor use.
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 |
|---|---|---|
| Quinapril 40 mg | Drug | – |
| Quinapril 10 mg and amlodipine 5 mg | Drug | – |
Primary outcome
Heart rate variability
9 secondary outcomes
Tolerability
Renin, aldosterone
MMPs
Oxidative stress
Norepinephrine
Lactate
Exercise tolerance at 20 and -8 degree celsius
Blood pressure
Impact of selected pharmacogenetic polymorphisms
Results and safety
The study was stopped early (reason given: Very difficult to recruit patients/slow recruitment(2 patients in nearly 2 years).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2008.
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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.
Michel White, MD principal investigator
Montreal Heart Institute
Simon de Denus, B. Pharm, MSc principal investigator
Faculty of Pharmacy, University of Montreal/Montreal Heart Institute
Jacques de Champlain, MD, PhD principal investigator
Faculty of Medicine, University of Montreal
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 Quinapril 40 mg and Quinapril 10 mg and amlodipine 5 mg in people with Hypertension, run by Montreal Heart Institute 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 18 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: stopped early, as of the sponsor's last update on 6 May 2008. 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 was stopped early (reason given: Very difficult to recruit patients/slow recruitment(2 patients in nearly 2 years).). 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?
Heart rate variability. 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 6 May 2008.