HypertensionPhase 4EXAMNCT01167153
Effectiveness of Valsartan/Amlodipine (EXforge®) and Nifedipine treAtment coMparison in Treating Chinese Hypertensive Patients
A Phase 4 study testing Valsartan/Amlodipine and Nifedipine in people with Hypertension, run by Novartis at 1 site in China.
Trial summary
The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Valsartan/Amlodipine and Nifedipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Apr 2011
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker)
Who cannot join
- Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization.
- Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin >8.0%)
- Patients had evidence of hepatic disease or renal impairment
- Other exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease.
- Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.
- Other protocol-defined inclusion/exclusion criteria applied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12 Weeks, Multi-center, Open Label, Randomized, Active Drug Parallel Control Trial to Compare the Effectiveness of Valsartan/Amlodipine and Nifedipine in Treating Chinese Hypertensive Patients Not Respond to Mono Antihypertensive Treatment
The purpose of this study was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.
- Conditions
- Hypertension
- Being tested
- Valsartan/Amlodipine, Nifedipine
- Keywords
- Hypertension, Valsartan Amlodipine single pill combination, BP control, ABPM, Hypertensive patients not adequately controlled by mono antihypertensive drugs
- 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
Also called Exforge®
Valsartan/Amlodipine 80/5mg single pill combination (SPC)
NifedipineDrug
Also called Adalat
Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg
| Study group | Role | What they receive |
|---|---|---|
| Valsartan/amlodipine | Experimental | Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. Receives: Drug: Valsartan/Amlodipine |
| Nifedipine | Active comparator | Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)
The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.
Measured: Baseline, 12 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)
The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.
Measured: Baseline, 12 weeks
Secondary outcomes (5)
Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)
Effective SBP control rate was defined as proportion of subjects in whom MSSBP < 140 mmHg or MSSBP reduction ≥ 20 mmHg from baseline.
Effective DBP control rate was defined as proportion of subjects in whom MSDBP < 90 mmHg or MSDBP reduction ≥10 mmHg from baseline.
Measured: Baseline, 12 weeks
Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks
Blood Pressure (BP) target was defined as mean sitting BP<140/90 mm Hg in non-diabetic patients and<130/80 mm Hg in diabetic patients at 12 weeks.
Measured: 12 weeks
Change From Baseline in Orthostatic SBP and DBP at 12 Weeks
The arm with higher sitting blood pressure was selected for all examinations throughout the study. Orthostatic blood pressure was measured when subject stood for 1 minute. Orthostatic blood pressures were measured at screening and each visit.
Measured: Baseline, 12 weeks
Change From Baseline in Sitting Pulse at 12 Weeks
Sitting pulse was measured by sphygmomanometer after subject sat for 5 minutes at clinic during each visit.
Measured: Baseline, 12 weeks
Change From Baseline in Orthostatic Pulse at 12 Weeks
Orthostatic pulse was measured by sphygmomanometer when subject stood for 1 minute at clinic during each visit.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2011
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 (2)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
- 564 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
- NCT01167153
- Sponsor's protocol ID
- CVAA489ACN02
- Acronym
- EXAM
- Status last verified
- May 2012
- First submitted
- 20 Jul 2010
- Last updated
- 1 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Xu SK, Zeng WF, Li Y, Chen LL, Xie JH, Wang JG. Effects of the valsartan/amlodipine combination and nifedipine gastrointestinal therapeutic system monotherapy on brachial pulse pressure and radial augmentation index in hypertensive patients. Blood Press Monit. 2021 Aug 1;26(4):251-256. doi: 10.1097/MBP.0000000000000527.
PubMed 33734121Wang JG, Zeng WF, He YS, Chen LL, Wei M, Li ZP, Zhang BW, Li Y; EXAM Investigators. Valsartan/amlodipine compared to nifedipine GITS in patients with hypertension inadequately controlled by monotherapy. Adv Ther. 2013 Aug;30(8):771-83. doi: 10.1007/s12325-013-0048-x. Epub 2013 Aug 21.
PubMed 23963546
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Weeks, Multi-center, Open Label, Randomized, Active Drug Parallel Control Trial to Compare the Effectiveness of Valsartan/Amlodipine and Nifedipine in Treating Chinese Hypertensive Patients Not Respond to Mono Antihypertensive Treatment
- ClinicalTrials.gov ID
- NCT01167153
- Acronym / sponsor ID
- EXAM / CVAA489ACN02
- Conditions
- Hypertension
- Keywords
- Hypertension, Valsartan Amlodipine single pill combination, BP control, ABPM, Hypertensive patients not adequately controlled by mono antihypertensive drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Posted 1 Jun 2012
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 was to compare the efficacy and safety of Valsartan/Amlodipine (EXforge®) with nifedipine, as well as vascular function index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan/amlodipine | Experimental | Drug: Valsartan/AmlodipineValsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. |
| Nifedipine | Active comparator | Drug: NifedipineNifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker)
Key exclusion criteria (6 listed)
- Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization.
- Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin >8.0%)
- Patients had evidence of hepatic disease or renal impairment
- Other exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease.
- Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.
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/AmlodipineAlso: Exforge®Valsartan/Amlodipine 80/5mg single pill combination (SPC) | Drug | Valsartan/amlodipine |
| NifedipineAlso: AdalatNifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg | Drug | Nifedipine |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)
Time frame: Baseline, 12 weeks
The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher mean sitting diastolic blood pressure (MSDBP) was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)
Time frame: Baseline, 12 weeks
The sitting blood pressure was trough value (23-26 hours after drug administration) measured by sphygmomanometer. Blood pressure was measured on both arms and the arm with higher msDBP was used at visit 1 and following visits. Measurement of blood pressure was carried out 3 times at each visit on the selected arm. The results and mean value of three sitting blood pressures were recorded for analysis.
5 secondary outcomes
Percentage of Patients With Effective Systolic Blood Pressure (SBP) Control Rate and Effective Diastolic Blood Pressure (DBP) Control Rate at the Study End Point (12 Weeks)
Time frame: Baseline, 12 weeks
Percentage of Patients in Whom Blood Pressure Target Was Achieved at the Study End Point at 12 Weeks
Time frame: 12 weeks
Change From Baseline in Orthostatic SBP and DBP at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Sitting Pulse at 12 Weeks
Time frame: Baseline, 12 weeks
Change From Baseline in Orthostatic Pulse at 12 Weeks
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33734121Xu SK, Zeng WF, Li Y, Chen LL, Xie JH, Wang JG. Effects of the valsartan/amlodipine combination and nifedipine gastrointestinal therapeutic system monotherapy on brachial pulse pressure and radial augmentation index in hypertensive patients. Blood Press Monit. 2021 Aug 1;26(4):251-256. doi: 10.1097/MBP.0000000000000527.
- Derived from this study: PubMed 23963546Wang JG, Zeng WF, He YS, Chen LL, Wei M, Li ZP, Zhang BW, Li Y; EXAM Investigators. Valsartan/amlodipine compared to nifedipine GITS in patients with hypertension inadequately controlled by monotherapy. Adv Ther. 2013 Aug;30(8):771-83. doi: 10.1007/s12325-013-0048-x. Epub 2013 Aug 21.
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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/Amlodipine and Nifedipine in people with Hypertension, run by Novartis at 1 site in China.
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 1 inclusion and 6 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 1 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 China. 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 1 Jun 2012). 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 From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks) (time frame: Baseline, 12 weeks). The study lists 2 primary outcomes in all. 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 NCT01167153, which also lists 2 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 1 Jun 2012.