HypertensionPhase 3NCT00413413

Efficacy/Safety of Valsartan Plus Amlodipine and Valsartan Alone in Patients With Hypertension

A Phase 3 study testing Valsartan/amlodipine 80/5 mg, Valsartan 80 mg and Valsartan 160 mg in people with Hypertension, run by Novartis Pharmaceuticals at 19 sites 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

This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Hypertension
What is being tested?: Valsartan/amlodipine 80/5 mg, Valsartan 80 mg and Valsartan 160 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,134 participants
Where: 19 sitesChina
Study dates: Jan 2007to Nov 2007
Phase: Phase 3
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female outpatients >= 18 years and < 86 years
Patients with essential diastolic hypertension
At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and < 10 mmHg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmHg
At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg and < 100 mmHg
At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg and < 110 mmHg

Who cannot join

Severe hypertension >= 180/110 mmHg
Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2
History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
Malignant hypertension
All patients with Type I diabetes and those patients with Type 2 diabetes who are not well controlled based on the investigator's clinical judgment

Show all 17Show fewer

Pregnant or nursing women
History of heart failure
Angina pectoris
Second or third degree heart block
Life threatening or symptomatic arrhythmias
Clinically significant valvular heart disease
Evidence of a secondary form of hypertension
Known or moderate malignant retinopathy
Evidence of hepatic disease
Evidence of renal impairment
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

China19 sites

Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences
Beijing, 100020
Beijing General Hospital of Beijing Military Region
Beijing, 100700
Beijing Hospital
Beijing, 100730
The First People's Hospital of Hangzhou
Hangzhou, 310006
The Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, 310006
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, 310007
Southeast University Affiliated Zhong Da Hospital
Nanjing, 210009
The First Affiliated Hospital of Nanjing Medical University
Nanjing, 210029
Second Military Medical University Affiliated Changzheng Hospital
Shanghai, 200003
Department of cardiology, Ruijin hospital;
Shanghai, 200025
Department of cardiology, Ruijin hospital
Shanghai, 200025
Fudan University affiliated zhongshan hospital
Shanghai, 200032
Second Military Medical University Affiliated Changhai Hospital
Shanghai, 200433
The First Affiliated Hospital of China Medical University
Shenyang, 110001
The people's Hospital of Liaoning Province
Shenyang, 110016
Second Hospital of Hebei University of Medical Sciences
Shijiazhuang, 050050
The People's Hospital of Hebei Provincial
Shijiazhuang, 050051
The Second Affiliated Hospital of Soochow University
Suzhou, 215004
The First Affiliated Hospital of Soochow University
Suzhou, 215006

Other trials in China

About this study

Official title: A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controled, Parallel Study, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Valsartan 80 mg and Valsartan 160 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80 mg Monotherapy.

This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.

Conditions: Hypertension
Being tested: Valsartan/amlodipine 80/5 mg, Valsartan 80 mg, Valsartan 160 mg
Keywords: Hypertension, valsartan, amlodipine, high blood 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/amlodipine 80/5 mgDrug
1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
Valsartan 80 mgDrug
1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
Valsartan 160 mgDrug
1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Study groups in NCT00413413
Study group	Role	What they receive
Valsartan/amlodipine 80/5 mg	Experimental	Not described Receives: Drug: Valsartan/amlodipine 80/5 mg
Valsartan 80 mg	Active comparator	Not described Receives: Drug: Valsartan 80 mg
Valsartan 160 mg	Active comparator	Not described Receives: Drug: Valsartan 160 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Measured: Baseline to end of study (Week 8)

Secondary outcomes (4)

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Measured: Baseline to end of study (Week 8)
Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)
A diastolic blood pressure response was defined as a msDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Measured: Baseline to end of study (Week 8)
Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)
Diastolic blood pressure control was defined as a msDBP < 90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Measured: End of study (Week 8)
Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
Overall blood pressure control rate was defined as a msSBP/msDBP < 140/90 mmHg at the end of the study (Week 8). Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.
Measured: End of study (Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Nov 2007

First posted19 Dec 2006 (estimated)
Study startJan 2007
Primary completionNov 2007
Study completionNov 2007

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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00413413
Sponsor's protocol ID: CVAA489A2316
Status last verified: Apr 2011
First submitted: 18 Dec 2006
Last updated: 28 Apr 2011
Results posted: Yes, on ClinicalTrials.gov

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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controled, Parallel Study, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Valsartan 80 mg and Valsartan 160 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 80 mg Monotherapy.
ClinicalTrials.gov ID: NCT00413413
Acronym / sponsor ID: CVAA489A2316
Conditions: Hypertension
Keywords: Hypertension, valsartan, amlodipine, high blood pressure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,134 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 19 Dec 2006 (estimated)
Results: Posted 14 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Valsartan/amlodipine 80/5 mg	Experimental	Drug: Valsartan/amlodipine 80/5 mg
Valsartan 80 mg	Active comparator	Drug: Valsartan 80 mg
Valsartan 160 mg	Active comparator	Drug: Valsartan 160 mg

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female outpatients >= 18 years and < 86 years
Patients with essential diastolic hypertension
At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and < 10 mmHg; patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmHg
At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg and < 100 mmHg
At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg and < 110 mmHg

Key exclusion criteria (17 listed)

Severe hypertension >= 180/110 mmHg
Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2
History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
Malignant hypertension

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 80/5 mg1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily	Drug	Valsartan/amlodipine 80/5 mg
Valsartan 80 mg1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily	Drug	Valsartan 80 mg
Valsartan 160 mg1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily	Drug	Valsartan 160 mg

Primary outcome

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated.

4 secondary outcomes

Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Percentage of Patients Achieving a Diastolic Blood Pressure Response at the End of the Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Percentage of Patients Achieving Diastolic Blood Pressure Control at the End of the Study (Week 8)
Time frame: End of study (Week 8)
Percentage of Patients Achieving Overall Blood Pressure Control at the End of the Study (Week 8)
Time frame: End of study (Week 8)

Results and safety

Results posted to the registry on 14 Sep 2009, 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 80/5 mg	0	0
Valsartan 80 mg	1,134	918
Valsartan 160 mg	0	0

Primary outcome: Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

Time frame: Baseline to end of study (Week 8). Least squares mean (Standard Error). Unit: mmHg

Measure	Valsartan/Amlodipine 80/5 mg n = 308	Valsartan 80 mg n = 306	Valsartan 160 mg n = 302
Value	-10.8 (0.42)	-6.3 (0.42)	-7.2 (0.42)

Population analysed: Full-set analysis population: All randomized patients who had a baseline and at least one post-baseline efficacy measurement. For patients who did not complete the Week 8 assessment, a last observation carried forward (LOCF) approach was used.

4 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 80/5 mg	4 of 308 (1.3%)	0 of 308 (0%)	Not reported
Valsartan 80 mg	0 of 307 (0%)	0 of 307 (0%)	Not reported
Valsartan 160 mg	4 of 303 (1.3%)	0 of 303 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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

19 sites 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 80/5 mg, Valsartan 80 mg and Valsartan 160 mg in people with Hypertension, run by Novartis Pharmaceuticals at 19 sites 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 5 inclusion and 17 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 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites 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 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?

Yes. Results are posted in the registry (first posted 14 Sep 2009). 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 Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8) (time frame: Baseline to end of study (Week 8)). 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 NCT00413413.

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 28 Apr 2011.