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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

China1 site

Novartis Pharmaceuticals
Beijing

Other trials in China

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 groups in NCT01167153
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.

May 2010Apr 2011

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)

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 33734121
Wang 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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

Results posted to the registry on 1 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Valsartan/Amlodipine	282	264
Nifedipine	282	249

Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at the Study End Point (12 Weeks)

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Valsartan/Amlodipine n = 267	Nifedipine n = 265
Value	-16.8 (11.69)	-10.6 (12.02)

Population analysed: ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSSBP after baseline.

Primary outcome: Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at the Study End Point (12 Weeks)

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Valsartan/Amlodipine n = 267	Nifedipine n = 265
Value	-8.5 (8.52)	-4.8 (8.89)

Population analysed: ITT (intention to treatment) population: all randomised subjects who had baseline assessment and at least one assessment record of MSDBP after baseline.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valsartan/Amlodipine	0 of 282 (0%)	14 of 282 (5%)	Not reported
Nifedipine	1 of 282 (0.4%)	32 of 282 (11.3%)	Not reported

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.