HypertensionPhase 4NCT00994253
Evaluating the Effect of Aliskiren Versus HCTZ on Coronary Flow Reserve in Hypertensive Type II Diabetics
A Phase 4 study testing Aliskiren and Hydrochlorothiazide in people with Hypertension and Diabetes Type 2, run by Corewell Health East at 1 site in United States.
Trial summary
The purpose of this study is to assess the effect of Tekturna (aliskiren), in combination with an ACE and calcium channel blocker in hypertensive patients diagnosed with Type II diabetes. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Diabetes Type 2
- What is being tested?
- Aliskiren and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 2012
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85
- Diagnosed with Type II Diabetes and Hypertension
- Taking either ACE or ARB in addition to any other antihypertensive medication excluding aliskiren
- Blood Pressure >130/80
Who cannot join
- Serum Potassium >5.2 mmol/L
- History of any cardiovascular event (stroke, TIA, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1.
- History of MI
- Documented ejection fraction of <50%
- Hypertension (at Screening): any patient with msSBP ≥ 180 mmHg or msDBP ≥ 110 mmHg
- Congestive Heart Failure NYHA class III and IV
Show all 27Show fewer
- Concomitant treatment with two (2) or more renin-angiotensin-aldosterone system blocking agents, e.g. ACE inhibitor, ARB or aldosterone-antagonist.
- Unstable serum creatinine
- Second (II) or third (III) degree heart block without a pacemaker
- Concurrent potentially life threatening arrythmia or other uncontrolled arrythmia
- Clinically significant valvular heart disease
- Known renal artery stenosis
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drugs including, but not limited to, any of the following:
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection (patients with previous bariatric surgery>6 months prior to Visit 1 are allowed to participate).
- Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
- Evidence of hepatic disease as determined by any one of the following: SGPT value exceeding 3x Upper Limit of Normal (ULN) at Visit 1, a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
- History of malignancy other than basal cell skin cancer that is likely to reduce the subject's life span to less than 2 years.
- Any concurrent life threatening condition with a life expectancy less than 2 years
- History or evidence of drug or alcohol abuse with the last 12 months
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- History of hypersensitively to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- Any condition that in the opinion of the investigator would jeopardized the evaluation of efficacy or safety
- Persons directly involved in the execution of this protocol
- Pregnant or nursing (lactating) women
- Women of Child Bearing Potential unless post menopausal for at least one year, surgically sterile or using effective methods of contraception as defined by local Health Authorities.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: A Prospective, Randomized, Open-label Clinical Trial to Evaluate the Effect of Tekturna (Aliskiren), Angiotensin Inhibitors, Diuretics, and Calcium Channel Blockers on Coronary Flow Reserve in Patients With Type II Diabetes and Hypertension
The purpose of this study is to assess the effect of Tekturna (aliskiren), in combination with an ACE and calcium channel blocker in hypertensive patients diagnosed with Type II diabetes.
Read the detailed description
This study focuses on diabetic patients who are already on any blood pressure-lowering medication (excluding Tekturna) in addition to either an ACE inhibitor or an ARB (angiotensin receptor blocker) and still have a blood pressure greater than 130/80 mm Hg. The purpose of the study is to compare the effects of two different blood pressure treatment regimens, each containing three medications, on heart function in diabetics with uncontrolled hypertension. The two treatments are 1) lisinopril (an ACE inhibitor that works by reducing blood pressure) plus amlodipine (a calcium channel blocker that reduces blood pressure) plus aliskiren (a renin inhibitor, which also reduces blood pressure), or 2) lisinopril plus amlodipine plus hydrochlorothiazide (a diuretic, or "water pill"). Participants will have their coronary flow reserve - which is a measure of coronary vessel function, a predictor of future cardiovascular events - and a number of cardiovascular biomarkers in blood and urine at baseline and after 6 months of treatment. In this manner hydrochlorothiazide will be compared with aliskiren, which researchers think will have a better effect on heart artery blood flow.
- Conditions
- Hypertension, Diabetes Type 2
- Being tested
- Aliskiren, Hydrochlorothiazide
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AliskirenDrug
Also called Tekturna
Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily.
HydrochlorothiazideDrug
Also called HCTZ
Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren | Experimental | Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.
Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg Receives: Drug: Aliskiren |
| Hydrochlorothiazide | Active comparator | HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.
Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg Receives: Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess the effect of a multimodal drug therapy regimen including the renin inhibitor Tekturna (aliskiren), an ACE inhibitor, and a calcium channel blocker on coronary flow reserve (CFR) in hypertensive Type II diabetics.
CFR will be assessed by a PET-based imaging technique.
Measured: 6 months
Secondary outcomes (1)
Secondary measures include evaluation of serum and urine biomarkers related to endothelial function, the renin-angiotensin system, oxidative stress, and inflammation.
Biomarkers include asymmetric dimethylarginine, B-type natriuretic peptide, plasma renin activity, high-sensitivity C-reactive protein, adiponectin, aldosterone, angiotensinogen, and hemoglobin A1c.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startAug 2009 (estimated)
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Due to safety concerns re: the concomitant use of aliskiren with an ACEi or ARB.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Pam Marcovitz, MD, Corewell Health East
- Investigators
- Pamela A Marcovitz, MD, Principal investigator, Beaumont Health System, Royal Oak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994253
- Sponsor's protocol ID
- 2009-083
- Status last verified
- Sep 2017
- First submitted
- 12 Oct 2009
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label Clinical Trial to Evaluate the Effect of Tekturna (Aliskiren), Angiotensin Inhibitors, Diuretics, and Calcium Channel Blockers on Coronary Flow Reserve in Patients With Type II Diabetes and Hypertension
- ClinicalTrials.gov ID
- NCT00994253
- Acronym / sponsor ID
- 2009-083
- Conditions
- Hypertension, Diabetes Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to safety concerns re: the concomitant use of aliskiren with an ACEi or ARB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Aug 2009 (estimated)
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 14 Oct 2009 (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 assess the effect of Tekturna (aliskiren), in combination with an ACE and calcium channel blocker in hypertensive patients diagnosed with Type II diabetes.
Detailed description
This study focuses on diabetic patients who are already on any blood pressure-lowering medication (excluding Tekturna) in addition to either an ACE inhibitor or an ARB (angiotensin receptor blocker) and still have a blood pressure greater than 130/80 mm Hg. The purpose of the study is to compare the effects of two different blood pressure treatment regimens, each containing three medications, on heart function in diabetics with uncontrolled hypertension. The two treatments are 1) lisinopril (an ACE inhibitor that works by reducing blood pressure) plus amlodipine (a calcium channel blocker that reduces blood pressure) plus aliskiren (a renin inhibitor, which also reduces blood pressure), or 2) lisinopril plus amlodipine plus hydrochlorothiazide (a diuretic, or "water pill"). Participants will have their coronary flow reserve - which is a measure of coronary vessel function, a predictor of future cardiovascular events - and a number of cardiovascular biomarkers in blood and urine at baseline and after 6 months of treatment. In this manner hydrochlorothiazide will be compared with aliskiren, which researchers think will have a better effect on heart artery blood flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aliskiren | Experimental | Drug: AliskirenAliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg |
| Hydrochlorothiazide | Active comparator | Drug: HydrochlorothiazideHCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-85
- Diagnosed with Type II Diabetes and Hypertension
- Taking either ACE or ARB in addition to any other antihypertensive medication excluding aliskiren
- Blood Pressure >130/80
Key exclusion criteria (27 listed)
- Serum Potassium >5.2 mmol/L
- History of any cardiovascular event (stroke, TIA, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1.
- History of MI
- Documented ejection fraction of <50%
- Hypertension (at Screening): any patient with msSBP ≥ 180 mmHg or msDBP ≥ 110 mmHg
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 |
|---|---|---|
| AliskirenAlso: TekturnaAliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily. | Drug | Aliskiren |
| HydrochlorothiazideAlso: HCTZHydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily | Drug | Hydrochlorothiazide |
Primary outcome
The primary objective is to assess the effect of a multimodal drug therapy regimen including the renin inhibitor Tekturna (aliskiren), an ACE inhibitor, and a calcium channel blocker on coronary flow reserve (CFR) in hypertensive Type II diabetics.
Time frame: 6 months
CFR will be assessed by a PET-based imaging technique.
1 secondary outcome
Secondary measures include evaluation of serum and urine biomarkers related to endothelial function, the renin-angiotensin system, oxidative stress, and inflammation.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Pamela A Marcovitz, MD principal investigator
Beaumont Health System, Royal Oak
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 Aliskiren and Hydrochlorothiazide in people with Hypertension and Diabetes Type 2, run by Corewell Health East at 1 site in United States.
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 4 inclusion and 27 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: withdrawn, as of the sponsor's last update on 2 Oct 2017. 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 States. 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 withdrawn before enrolling participants, so there are no results.
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 objective is to assess the effect of a multimodal drug therapy regimen including the renin inhibitor Tekturna (aliskiren), an ACE inhibitor, and a calcium channel blocker on coronary flow reserve (CFR) in hypertensive Type II diabetics. (time frame: 6 months). 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 2 Oct 2017.