Essential HypertensionPhase 2/3NCT00425373

Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

A Phase 2/3 study testing Valsartan + amlodipine 40/2.5 mg, Valsartan + amlodipine 40/5 mg and Valsartan + amlodipine 80/2.5 mg in people with Essential Hypertension, run by Novartis Pharmaceuticals at 1 site in Japan.

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 is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Essential Hypertension
What is being tested?: Valsartan + amlodipine 40/2.5 mg, Valsartan + amlodipine 40/5 mg and Valsartan + amlodipine 80/2.5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,474 participants
Where: 1 siteJapan
Study dates: Nov 2006to Mar 2008
Phase: Phase 2/3
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with essential hypertension measured by electronic hemodynamometer. - - Patients must satisfy the following criteria.
MSDBP <110 mmHg and MSSBP <180 mmHg at Visit 1
MSDBP ≥ 90 mmHg and < 110 mmHg and MSSBP < 180 mmHg at Visit 2
MSDBP ≥ 95 mmHg and < 110 mmHg and MSSBP < 180 mmHg at Visit 3
The absolute difference in MSDBP between Visit 2 and 3 is ≤ 10 mmHg
Male or female outpatients.
Aged => 20 and =< 80 years (at the time of signing informed consent).
Patients who have written informed consent to participate in this study.

Who cannot join

Pregnant women, nursing (lactating) mothers, women suspected of being pregnant, or women who wish to be pregnant during the study, women of child-bearing potential.
Patients with secondary hypertension or suspected of having secondary hypertension.
Patients with a history of malignant hypertension.
Patients with an inability to completely discontinue all prior antihypertensive medications safely for a period of 12 weeks as required by the protocol.
Patients with or with a history of any of the following diseases or signs: Cardiac disease, renal disease, cerebrovascular disorder
Patients with a clinically significant allergy (asthma on pharmacotherapy, multi-drug allergy, or drug-induced or food-induced anaphylactic reactions).

Show all 20Show fewer

Patients hypersensitive to AII receptor antagonists, calcium channel blockers or dihydropyridine derivatives.
Known moderate or malignant retinopathy.
Patients with or with a history of pancreatitis. Patients with pancreatic injury, or evidence of impaired pancreatic function/injury within 12 months of Visit 1.
Patients with any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
Patients with volume depletion based on the investigator's or subinvestigator's clinical judgment using vital signs, skin turgor, moistness of mucous membrane and laboratory values.
Patients who are found to have low Na and K (Na <130 mEq/L, K <3.3mEq/L) or high in these parameters (Na ≥ 152 mEq/L, K ≥ 5.2 mEq/L) by laboratory tests at Visit 1.
Patients with type I diabetes mellitus on treatment with insulin, or patients with type II diabetes with poor glucose control defined as a glycosylated hemoglobin (HbA1c) > 8.0% at Visit 1.
Patients with or with a history of malignant tumors including leukemia and lymphoma, treated or untreated, within the past 5 years of Visit 1 whether or not there is evidence of local recurrence or metastases (except for localized basal cell carcinoma of the skin).
Patients with any severe, life-threatening disease within the past 5 years. Patients with a history of autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus.
Any surgical or medical condition, which in the opinion of the investigator or subinvestigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirement of the study or completing the trial period.
Patients who have with or with a history of drug or alcohol abuse within the last 2 years of Visit 1. Patients who have received other investigational product within 12 weeks of Visit 1.
Any chronic inflammatory condition needing chronic anti-inflammatory drug therapy.
Persons directly involved in the execution of this study.
Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or subinvestigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Novartis Pharmaceuticals
Tokyo, 11111

Other trials in Japan

About this study

Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of 8-week Treatment With Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined and Alone in Essential Hypertensive Patients

Conditions: Essential Hypertension
Being tested: Valsartan + amlodipine 40/2.5 mg, Valsartan + amlodipine 40/5 mg, Valsartan + amlodipine 80/2.5 mg, Valsartan + amlodipine 80/5 mg, Valsartan 40 mg
Keywords: Hypertension, Valsartan, Amlodipine, high blood pressure
Medical subject headings: Essential Hypertension, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Valsartan + amlodipine 40/2.5 mgDrug
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 40/5 mgDrug
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/2.5 mgDrug
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan + amlodipine 80/5 mgDrug
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 40 mgDrug
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Valsartan 80 mgDrug
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Amlodipine 2.5 mgDrug
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Amlodipine 5 mgDrug
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
PlaceboDrug
4 tablet and 2 capsule placebos taken once daily

Study groups in NCT00425373
Study group	Role	What they receive
Valsartan + amlodipine 40/2.5 mg	Experimental	Not described Receives: Drug: Valsartan + amlodipine 40/2.5 mg
Valsartan + amlodipine 40/5 mg	Experimental	Not described Receives: Drug: Valsartan + amlodipine 40/5 mg
Valsartan + amlodipine 80/2.5 mg	Experimental	Not described Receives: Drug: Valsartan + amlodipine 80/2.5 mg
Valsartan + amlodipine 80/5 mg	Experimental	Not described Receives: Drug: Valsartan + amlodipine 80/5 mg
Valsartan 40 mg	Active comparator	Not described Receives: Drug: Valsartan 40 mg
Valsartan 80 mg	Active comparator	Not described Receives: Drug: Valsartan 80 mg
Amlodipine 2.5 mg	Active comparator	Not described Receives: Drug: Amlodipine 2.5 mg
Amlodipine 5 mg	Active comparator	Not described Receives: Drug: Amlodipine 5 mg
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

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)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
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)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Measured: Baseline to end of study (Week 8)
Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Measured: Baseline to end of study (Week 8)
Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Measured: Baseline to end of study (Week 8)
Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Measured: Baseline to 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.

Nov 2006Mar 2008

First posted23 Jan 2007 (estimated)
Study startNov 2006
Primary completionMar 2008
Study completionMar 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.
Other trials for Essential 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,474 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00425373
Sponsor's protocol ID: CVAA489A1301
Status last verified: Apr 2011
First submitted: 22 Jan 2007
Last updated: 29 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?

See locations

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All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of 8-week Treatment With Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined and Alone in Essential Hypertensive Patients
ClinicalTrials.gov ID: NCT00425373
Acronym / sponsor ID: CVAA489A1301
Conditions: Essential Hypertension
Keywords: Hypertension, Valsartan, Amlodipine, high blood pressure
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,474 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 23 Jan 2007 (estimated)
Results: Posted 4 Feb 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 9

Arm	Type	Receives
Valsartan + amlodipine 40/2.5 mg	Experimental	Drug: Valsartan + amlodipine 40/2.5 mg
Valsartan + amlodipine 40/5 mg	Experimental	Drug: Valsartan + amlodipine 40/5 mg
Valsartan + amlodipine 80/2.5 mg	Experimental	Drug: Valsartan + amlodipine 80/2.5 mg
Valsartan + amlodipine 80/5 mg	Experimental	Drug: Valsartan + amlodipine 80/5 mg
Valsartan 40 mg	Active comparator	Drug: Valsartan 40 mg
Valsartan 80 mg	Active comparator	Drug: Valsartan 80 mg
Amlodipine 2.5 mg	Active comparator	Drug: Amlodipine 2.5 mg
Amlodipine 5 mg	Active comparator	Drug: Amlodipine 5 mg
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patients with essential hypertension measured by electronic hemodynamometer. - - Patients must satisfy the following criteria.
Male or female outpatients.
Aged => 20 and =< 80 years (at the time of signing informed consent).
Patients who have written informed consent to participate in this study.

Key exclusion criteria (20 listed)

Pregnant women, nursing (lactating) mothers, women suspected of being pregnant, or women who wish to be pregnant during the study, women of child-bearing potential.
Patients with secondary hypertension or suspected of having secondary hypertension.
Patients with a history of malignant hypertension.
Patients with an inability to completely discontinue all prior antihypertensive medications safely for a period of 12 weeks as required by the protocol.
Patients with or with a history of any of the following diseases or signs: Cardiac disease, renal disease, cerebrovascular disorder

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 40/2.5 mgValsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily	Drug	Valsartan + amlodipine 40/2.5 mg
Valsartan + amlodipine 40/5 mgValsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily	Drug	Valsartan + amlodipine 40/5 mg
Valsartan + amlodipine 80/2.5 mgValsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily	Drug	Valsartan + amlodipine 80/2.5 mg
Valsartan + amlodipine 80/5 mgValsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily	Drug	Valsartan + amlodipine 80/5 mg
Valsartan 40 mgValsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily	Drug	Valsartan 40 mg
Valsartan 80 mgValsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily	Drug	Valsartan 80 mg
Amlodipine 2.5 mgAmlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily	Drug	Amlodipine 2.5 mg
Amlodipine 5 mgAmlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily	Drug	Amlodipine 5 mg
Placebo4 tablet and 2 capsule placebos taken once daily	Drug	Placebo

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)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.

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 MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)
Time frame: Baseline to end of study (Week 8)

Results and safety

Results posted to the registry on 4 Feb 2011, 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 40/2.5 mg	159	154
Valsartan + Amlodipine 40/5 mg	167	164
Valsartan + Amlodipine 80/2.5 mg	160	157
Valsartan + Amlodipine 80/5 mg	162	160
Valsartan 40 mg	169	159
Valsartan 80 mg	163	154
Amlodipine 2.5 mg	161	154
Amlodipine 5 mg	161	151
Placebo	166	148

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: mm Hg

Measure	Valsartan + Amlodipine 40/2.5 mg n = 159	Valsartan + Amlodipine 40/5 mg n = 167	Valsartan + Amlodipine 80/2.5 mg n = 160	Valsartan + Amlodipine 80/5 mg n = 162	Valsartan 40 mg n = 169	Valsartan 80 mg n = 163	Amlodipine 2.5 mg n = 161	Amlodipine 5 mg n = 161	Placebo n = 166
Value	-13.5 (0.62)	-16.5 (0.60)	-12.6 (0.62)	-17.0 (0.61)	-8.5 (0.60)	-8.8 (0.61)	-10.3 (0.61)	-13.4 (0.61)	-4.8 (0.61)

Population analysed: Intent-to-treat (ITT): All randomized patients who had a baseline and at least one post-baseline assessment of the variable analyzed. Baseline is the Week 0 value and end of study is the value at Week 8 or the last observation carried forward (LOCF) value.

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
Placebo	2 of 166 (1.2%)	17 of 166 (10.2%)	Not reported
Valsartan 40 mg	0 of 169 (0%)	23 of 169 (13.6%)	Not reported
Valsartan 80 mg	0 of 163 (0%)	19 of 163 (11.7%)	Not reported
Amlodipine 2.5 mg	1 of 161 (0.6%)	12 of 161 (7.5%)	Not reported
Valsartan + Amlodipine 40/2.5 mg	0 of 159 (0%)	17 of 159 (10.7%)	Not reported
Valsartan + Amlodipine 80/2.5 mg	1 of 160 (0.6%)	9 of 160 (5.6%)	Not reported
Amlodipine 5 mg	0 of 161 (0%)	12 of 161 (7.5%)	Not reported
Valsartan + Amlodipine 40/5 mg	1 of 167 (0.6%)	20 of 167 (12%)	Not reported
Valsartan + Amlodipine 80/5 mg	0 of 162 (0%)	14 of 162 (8.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Japan study chair

Sponsor GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 20 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 29 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 1 site in Japan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 4 Feb 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 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 NCT00425373.

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 29 Apr 2011.