HypertensionPhase 4NCT00523549
The Effects of Systolic Blood Pressure Lowering on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction
A Phase 4 study testing valsartan and amlodipine in people with Hypertension and Diastolic Dysfunction, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of treatment with valsartan + amlodipine to a target systolic blood pressure (SBP)<130 mmHg compared to the Joint National Commission on the Treatment of Hypertension 7 recommended target SBP of <140 mmHg on the intrinsic diastolic properties of the myocardium in… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypertension, Diastolic Dysfunction
- What is being tested?
- valsartan and amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jan 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45 years or older
- Male and female patients are eligible. Female patients must be post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as a double barrier method with spermicide, an intra-uterine device, or hormonal contraceptives. Post-menopausal women on a stable dose of hormone replacement therapy (HRT) for at least three (3) months prior to the screening visit are eligible for the study.
- Uncontrolled systolic hypertension on a maximum of two (2) antihypertensive medications at the time of screening.
- Echocardiographic ejection fraction ≥50% and evidence of diastolic dysfunction.
- Provide written informed consent to participate in the study prior to any screening or study procedures
- Have the ability to communicate well and comply with all study requirements
Who cannot join
- Severe hypertension defined as a MSSBP >200 mmHg and/or MSDBP >120 mmHg.
- History of a secondary cause of hypertension including but not limited to: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
- Ejection fraction <50 %
- History of stroke, transient ischemic attack, myocardial infarction, coronary artery bypass graft surgery, or unstable angina pectoris within 6 months of screening
- Presence of clinically significant ventricular or supraventricular arrhythmias (e.g. atrial fibrillation/flutter)
- History of congestive heart failure
Show all 16Show fewer
- History of diabetes mellitus
- History of renal impairment with serum creatinine >2.0 mg/dL at screening, history of dialysis, or history of nephritic syndrome
- Antihypertensive therapy with three (3) or more medications at the time of screening
- Active and/or treated malignancy of any organ system within twelve (12) months of enrollment, with the exception of localized basal cell carcinoma of the skin
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml)
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: barrier method with spermicidal agent, an intrauterine device, hormonal contraceptives, or total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug including, but not limited to, any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active, or active inflammatory bowel syndrome within 12 months prior to Visit 1, currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction regarded as clinically meaningful by the investigator
- Pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury within 12 months prior to Visit 1
- Any serum AST or ALT elevation two (2) times the upper limit of normal
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Prospective, Randomized, Open-label Study With Blinded Outcome Evaluation to Evaluate the Effects of Systolic Blood Pressure Lowering to Different Targets (Less Than 130 mmHg vs. Less Than 140 mmHg) on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction
The purpose of this study is to determine the effects of treatment with valsartan + amlodipine to a target systolic blood pressure (SBP)<130 mmHg compared to the Joint National Commission on the Treatment of Hypertension 7 recommended target SBP of <140 mmHg on the intrinsic diastolic properties of the myocardium in patients with hypertension and echocardiographic evidence of diastolic dysfunction.
- Conditions
- Hypertension, Diastolic Dysfunction
- Being tested
- valsartan, amlodipine
- Keywords
- Hypertension, systolic blood pressure, diastolic dysfunction, valsartan, amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
Also called Diovan
160 mg or 320 mg tablets once a day
amlodipineDrug
Also called Norvasc
5 mg or 10 mg tablets once a day
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment regimen | Experimental | (Valsartan + Amlodipine to target SBP of < 140 mmHg) Receives: Drug: valsartan; Drug: amlodipine |
| Intensive treatment regimen | Experimental | (Valsartan + Amlodipine to target SBP < 130 mm Hg) Receives: Drug: valsartan; Drug: amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lateral Mitral Annular Myocardial Relaxation Velocity
Change from baseline in lateral mitral annular myocardial relaxation velocity (E') at Week 24
Measured: Baseline to 24 weeks after treatment
Secondary outcomes (6)
Change in Left Atrial Size
Change from baseline in left atrial size at Week 24
Measured: Baseline to 24 weeks after treatment
Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity
Change from baseline in peak E-wave velocity / lateral mitral annular myocardial relaxation velocity (E/E') at Week 24
Measured: Baseline to 24 weeks after treatment
Percent Change From Baseline in Vascular Stiffness
Percent change from baseline in Vascular Stiffness (measured by radial augmentation index [AI]) at Weeks 8 and 24
Measured: Baseline to 8 and 24 weeks after treatment
Change in Mean Sitting Systolic Blood Pressure (msSBP)
Change from baseline in msSBP at Weeks 8 and 24
Measured: Baseline to 8 and 24 weeks after treatment
Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Change from baseline in msDBP at Weeks 8 and 24
Measured: Baseline to 8 and 24 weeks after treatment
Change in Estimated Central Aortic Pressure
Change from baseline in estimated central aortic pressure at Weeks 8 and 24
Measured: Baseline to 8 and 24 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 posted31 Aug 2007 (estimated)
- Study startNov 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523549
- Sponsor's protocol ID
- CVAA489AUS01
- Status last verified
- Apr 2012
- First submitted
- 30 Aug 2007
- Last updated
- 23 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Solomon SD, Verma A, Desai A, Hassanein A, Izzo J, Oparil S, Lacourciere Y, Lee J, Seifu Y, Hilkert RJ, Rocha R, Pitt B; Exforge Intensive Control of Hypertension to Evaluate Efficacy in Diastolic Dysfunction Investigators. Effect of intensive versus standard blood pressure lowering on diastolic function in patients with uncontrolled hypertension and diastolic dysfunction. Hypertension. 2010 Feb;55(2):241-8. doi: 10.1161/HYPERTENSIONAHA.109.138529. Epub 2009 Dec 7.
PubMed 19996069
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Randomized, Open-label Study With Blinded Outcome Evaluation to Evaluate the Effects of Systolic Blood Pressure Lowering to Different Targets (Less Than 130 mmHg vs. Less Than 140 mmHg) on Diastolic Function Using Valsartan + Amlodipine in Patients With Hypertension and Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT00523549
- Acronym / sponsor ID
- CVAA489AUS01
- Conditions
- Hypertension, Diastolic Dysfunction
- Keywords
- Hypertension, systolic blood pressure, diastolic dysfunction, valsartan, amlodipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 31 Aug 2007 (estimated)
- Results
- Posted 10 Mar 2011
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 determine the effects of treatment with valsartan + amlodipine to a target systolic blood pressure (SBP)<130 mmHg compared to the Joint National Commission on the Treatment of Hypertension 7 recommended target SBP of <140 mmHg on the intrinsic diastolic properties of the myocardium in patients with hypertension and echocardiographic evidence of diastolic dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment regimen | Experimental | Drug: valsartan, Drug: amlodipine(Valsartan + Amlodipine to target SBP of < 140 mmHg) |
| Intensive treatment regimen | Experimental | Drug: valsartan, Drug: amlodipine(Valsartan + Amlodipine to target SBP < 130 mm Hg) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 45 years or older
- Male and female patients are eligible. Female patients must be post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as a double barrier method with spermicide, an intra-uterine device, or hormonal contraceptives. Post-menopausal women on a stable dose of hormone replacement therapy (HRT) for at least three (3) months prior to the screening visit are eligible for the study.
- Uncontrolled systolic hypertension on a maximum of two (2) antihypertensive medications at the time of screening.
- Echocardiographic ejection fraction ≥50% and evidence of diastolic dysfunction.
- Provide written informed consent to participate in the study prior to any screening or study procedures
Key exclusion criteria (16 listed)
- Severe hypertension defined as a MSSBP >200 mmHg and/or MSDBP >120 mmHg.
- History of a secondary cause of hypertension including but not limited to: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
- Ejection fraction <50 %
- History of stroke, transient ischemic attack, myocardial infarction, coronary artery bypass graft surgery, or unstable angina pectoris within 6 months of screening
- Presence of clinically significant ventricular or supraventricular arrhythmias (e.g. atrial fibrillation/flutter)
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 |
|---|---|---|
| valsartanAlso: Diovan160 mg or 320 mg tablets once a day | Drug | Intensive treatment regimen, Standard treatment regimen |
| amlodipineAlso: Norvasc5 mg or 10 mg tablets once a day | Drug | Intensive treatment regimen, Standard treatment regimen |
Primary outcome
Change in Lateral Mitral Annular Myocardial Relaxation Velocity
Time frame: Baseline to 24 weeks after treatment
Change from baseline in lateral mitral annular myocardial relaxation velocity (E') at Week 24
6 secondary outcomes
Change in Left Atrial Size
Time frame: Baseline to 24 weeks after treatment
Change in Ratio of Peak E Wave Velocity/Lateral Mitral Annular Myocardial Relaxation Velocity
Time frame: Baseline to 24 weeks after treatment
Percent Change From Baseline in Vascular Stiffness
Time frame: Baseline to 8 and 24 weeks after treatment
Change in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline to 8 and 24 weeks after treatment
Change in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline to 8 and 24 weeks after treatment
Change in Estimated Central Aortic Pressure
Time frame: Baseline to 8 and 24 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19996069Solomon SD, Verma A, Desai A, Hassanein A, Izzo J, Oparil S, Lacourciere Y, Lee J, Seifu Y, Hilkert RJ, Rocha R, Pitt B; Exforge Intensive Control of Hypertension to Evaluate Efficacy in Diastolic Dysfunction Investigators. Effect of intensive versus standard blood pressure lowering on diastolic function in patients with uncontrolled hypertension and diastolic dysfunction. Hypertension. 2010 Feb;55(2):241-8. doi: 10.1161/HYPERTENSIONAHA.109.138529. Epub 2009 Dec 7.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 valsartan and amlodipine in people with Hypertension and Diastolic Dysfunction, run by Novartis Pharmaceuticals 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 6 inclusion and 16 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 23 Apr 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 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?
Yes. Results are posted in the registry (first posted 10 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Lateral Mitral Annular Myocardial Relaxation Velocity (time frame: Baseline to 24 weeks after treatment). 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 NCT00523549, 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 23 Apr 2012.