HypertensionPhase 3NCT00350168
Efficacy & Safety of Orally Administered Valsartan/Amlodipine Combo Therapy vs Amlodipine Monotherapy in Patients With Stage II Hypertension
A Phase 3 study testing valsartan + amlodipine in people with Hypertension, run by Novartis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- valsartan + amlodipine
- How many people
- 647 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Apr 2007
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.
Who cannot join
- History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
- Inability to stop all prior blood pressure medications safely
- Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
- Controlled blood pressure (systolic BP < 140 mmHg) taking more than 3 antihypertensive medications at screening
- Systolic BP ≥ 140 mmHg and < 180 mmHg taking more than two antihypertensive medications at screening
- Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening
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- History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina
- Type 1 diabetes
- Poorly controlled Type 2 diabetes
- History of heart failure
- Arrhythmia
- Significant valvular heart disease
- Active gout
- History of autoimmune diseases
- History of multiple drug allergies
- Liver disease
- Pancreatic injury within 1 year of screening
- Evidence of kidney impairment or history of dialysis
- Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed
- Pregnant or nursing (lactating) women
- History of malignancy of any organ system within the past five years
- Any severe, life-threatening disease within the past five years
- History of drug or alcohol abuse within the last 2 years.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals Corp
East Hanover, New Jersey, 07936
About this study
Official title: An 8-week Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combination Based Therapy Versus Amlodipine Monotherapy in Patients With Stage II Hypertension
The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).
- Conditions
- Hypertension
- Being tested
- valsartan + amlodipine
- Keywords
- Blood pressure, Venous pressure, Systolic pressure, Diastolic pressure, Pulse pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartan + amlodipineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in MSSBP at week 4
Secondary outcomes (4)
Change from baseline MSSBP after 2 and 8 weeks of treatment
Change from baseline MSDBP after 2, 4 and 8 weeks of treatment
Proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 8 weeks of treatment
Evaluation of safety and tolerability after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350168
- Sponsor's protocol ID
- CVAA489A2403
- Status last verified
- Nov 2016
- First submitted
- 7 Jul 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Destro M, Luckow A, Samson M, Kandra A, Brunel P. Efficacy and safety of amlodipine/valsartan compared with amlodipine monotherapy in patients with stage 2 hypertension: a randomized, double-blind, multicenter study: the EX-EFFeCTS Study. J Am Soc Hypertens. 2008 Jul-Aug;2(4):294-302. doi: 10.1016/j.jash.2008.01.004. Epub 2008 Jun 2.
PubMed 20409909
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combination Based Therapy Versus Amlodipine Monotherapy in Patients With Stage II Hypertension
- ClinicalTrials.gov ID
- NCT00350168
- Acronym / sponsor ID
- CVAA489A2403
- Conditions
- Hypertension
- Keywords
- Blood pressure, Venous pressure, Systolic pressure, Diastolic pressure, Pulse pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 10 Jul 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 evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older.
- Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.
Key exclusion criteria (25 listed)
- History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
- Inability to stop all prior blood pressure medications safely
- Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
- Controlled blood pressure (systolic BP < 140 mmHg) taking more than 3 antihypertensive medications at screening
- Systolic BP ≥ 140 mmHg and < 180 mmHg taking more than two antihypertensive medications at screening
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 |
|---|---|---|
| valsartan + amlodipine | Drug | – |
Primary outcome
Change from baseline in MSSBP at week 4
4 secondary outcomes
Change from baseline MSSBP after 2 and 8 weeks of treatment
Change from baseline MSDBP after 2, 4 and 8 weeks of treatment
Proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 8 weeks of treatment
Evaluation of safety and tolerability after 8 weeks of 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 18 Nov 2016.
- Results publication: PubMed 20409909Destro M, Luckow A, Samson M, Kandra A, Brunel P. Efficacy and safety of amlodipine/valsartan compared with amlodipine monotherapy in patients with stage 2 hypertension: a randomized, double-blind, multicenter study: the EX-EFFeCTS Study. J Am Soc Hypertens. 2008 Jul-Aug;2(4):294-302. doi: 10.1016/j.jash.2008.01.004. Epub 2008 Jun 2.
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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 3 study testing valsartan + amlodipine in people with Hypertension, run by Novartis 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 2 inclusion and 25 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 18 Nov 2016. 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 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 from baseline in MSSBP at week 4. 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 NCT00350168, 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 18 Nov 2016.