HypertensionPhase 3NCT00523744

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

A Phase 3 study testing Amlodipine, Olmesartan medoxomil and Amlodipine+valsartan in people with Hypertension, run by Novartis at 2 sites in 2 countries.

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 will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Amlodipine, Olmesartan medoxomil and Amlodipine+valsartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 257 participants
Where: 2 sitesin 2 countries
Study dates: Jul 2007to Dec 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients (>=18 years)
Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110 mmHg)
Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study.

Who cannot join

Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg)
Pregnant or nursing women
Treated hypertensive patients with controlled hypertension under current therapy
A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
prematurely discontinued the core study
failed to comply with the core study protocol
Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Germany1 site

Novartis Investigative Site, , Germany
Schwerin

Other trials in Germany

Location not given1 site

30 sites in Germany

About this study

Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg

Read the detailed description

Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

Conditions: Hypertension
Being tested: Amlodipine, Olmesartan medoxomil, Amlodipine+valsartan, Hydrochlorothiazide
Keywords: hypertension, valsartan, amlodipine
Medical subject headings: Hypertension

What participants receive

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

AmlodipineDrug
Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.
Olmesartan medoxomilDrug
Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.
Amlodipine+valsartanDrug
Also called Exforge
Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.
HydrochlorothiazideDrug
Also called Sandoz
Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.

Study groups in NCT00523744
Study group	Role	What they receive
Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ	Experimental	During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg. Receives: Drug: Amlodipine; Drug: Olmesartan medoxomil; Drug: Amlodipine+valsartan; Drug: Hydrochlorothiazide

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) During the Core Phase of the Study
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Measured: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Measured: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)

Secondary outcomes (10)

Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Measured: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Change in Sitting Pulse Pressure During the Core Phase of the Study
Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Measured: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Change in Sitting Pulse Rate During the Core Phase of the Study
Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Measured: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.
Measured: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 2 (Week 8) compared to Baseline in Phase 2 (week 4) or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 2 compared to Baseline in Phase 2.
Measured: Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)
Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Measured: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Change in Sitting Pulse Pressure During the Extension Phase of the Study
Pulse pressure is systolic pressure (SP) minus diastolic pressure (DP). The arm in which the highest sitting DPs were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, SP and DP were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Measured: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Change in Sitting Pulse Rate During the Extension Phase of the Study
Pulse rate was measured once for 30 seconds just prior to blood pressure measurements in the sitting position.
Measured: Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)
Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study
Normalized Blood Pressure was defined as a msSBP < 140 mmHg and/or a msDBP < 90 mmHg.
Measured: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study
Blood pressure response was defined as msSBP < 140 mmHg or a 20 mmHg decrease in msSBP at the end of Phase 3 compared to Baseline in Phase 3 or a msDBP < 90 mmHg or a 10 mmHg decrease in msDBP at the end of Phase 3 compared to Baseline in Phase 3.
Measured: Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)

Timeline

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

Jul 2007Dec 2007

First posted31 Aug 2007 (estimated)
Study startJul 2007
Primary completionDec 2007
Study completionDec 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.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 257 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00523744
Sponsor's protocol ID: CVAA489ADE06
Status last verified: Jul 2020
First submitted: 30 Aug 2007
Last updated: 4 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg
ClinicalTrials.gov ID: NCT00523744
Acronym / sponsor ID: CVAA489ADE06
Conditions: Hypertension
Keywords: hypertension, valsartan, amlodipine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 257 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 31 Aug 2007 (estimated)
Results: Posted 25 May 2011

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ	Experimental	Drug: Amlodipine, Drug: Olmesartan medoxomil, Drug: Amlodipine+valsartan, Drug: HydrochlorothiazideDuring the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the treatment Phase 2 of the study participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.

Who may qualify

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

Key inclusion criteria (4 listed)

Male or female patients (>=18 years)
Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110 mmHg)
Patients had to have a msSBP >= 140 mmHg and/or msDBP >= 90 mmHg at week 8 ie, end of core study.

Key exclusion criteria (7 listed)

Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg)
Pregnant or nursing women
Treated hypertensive patients with controlled hypertension under current therapy
A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
prematurely discontinued the core study

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
AmlodipineAmlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.	Drug	Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
Olmesartan medoxomilOlmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.	Drug	Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
Amlodipine+valsartanAlso: ExforgeFixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.	Drug	Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ
HydrochlorothiazideAlso: SandozHydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.	Drug	Amlodipine(AML)+olmesartan, AML+valsartan, AML+valsartan+HCTZ

Primary outcome

Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.
Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
The arm in which the highest sitting diastolic pressures were found at study entry was the arm used for all subsequent readings. A calibrated sphygmomanometer and appropriate size cuff were used to measure arterial sitting blood pressure (BP) at trough with the arm supported at the level of the heart. At each study visit, after having the patient in a sitting position for at least 5 minutes, systolic/diastolic blood pressure were measured 3 times at 1-2 minute intervals. A mean was calculated from the 3 measurements. A negative change indicates improvement.

10 secondary outcomes

Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Change in Sitting Pulse Pressure During the Core Phase of the Study
Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Change in Sitting Pulse Rate During the Core Phase of the Study
Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
Time frame: Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)
Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study
Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Change in Sitting Pulse Pressure During the Extension Phase of the Study
Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Change in Sitting Pulse Rate During the Extension Phase of the Study
Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)
Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study
Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study
Time frame: Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)

Results and safety

Results posted to the registry on 25 May 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
Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ	257	251

Primary outcome: Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study

Time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8). Mean (95% Confidence Interval). Unit: mmHg

Measure	Amlodipine+Valsartan - Phase 2 n = 175
Value	-9.13 (1.97)

Population analysed: Intent-to-treat population (ITT): All patients who took at least one dose of amlodipine plus valsartan who had at least one primary efficacy parameter evaluation. Patients who dropped out were included in the ITT population if there was any BP measurement available; their last available blood pressure measurement was used for the analysis.

Primary outcome: Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study

Time frame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12). Mean (95% Confidence Interval). Unit: mmHg

Measure	Amlodipine+Valsartan+HCTZ - Phase 3 n = 91
Value	-5.22 (-6.76 to -3.68)

Population analysed: Safety population: All patients who took at least one dose of amlodipine 10 mg plus valsartan 160 mg plus HCTZ 12.5 mg.

10 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
Phase 1 - Amlodipine+Olmesartan	1 of 257 (0.4%)	0 of 257 (0%)	Not reported
Phase 2 - Amlodipine+Valsartan	0 of 176 (0%)	0 of 176 (0%)	Not reported
Phase 3 - Amlodipine+Valsartan+HCTZ	0 of 91 (0%)	0 of 91 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
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 Pharmaceuticals study director

Sponsor GmbH

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amlodipine, Olmesartan medoxomil and Amlodipine+valsartan in people with Hypertension, run by Novartis at 2 sites in 2 countries.

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 4 inclusion and 7 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 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 25 May 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) During the Core Phase of the Study (time frame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)). 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 NCT00523744.

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 4 Aug 2020; AzTrials last refreshed its copy on 8 Nov 2026.