HypertensionPhase 3NCT00699192
Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 as Compared to Amlodipine/Valsartan 5/40 or to Amlodipine 5 mg Monotherapy in Patients 65 Years of Age and Older With Essential Hypertension
A Phase 3 study testing Amlodipine 5 mg, Valsartan 80 mg and Valsartan 40 mg in people with Hypertension, run by Novartis Pharmaceuticals at 18 sites in 10 countries.
Trial summary
To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine 5 mg, Valsartan 80 mg and Valsartan 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 965 participants
- Where
- 18 sitesin 10 countries
- Study dates
- May 2008to May 2009
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Provide written informed consent before any assessment was performed.
- Male or female at least 65 years of age.
- Diagnosed as having hypertension:
- At Visit 1/Screening, treatment naïve patients had to have a mean seated SBP ≥ 155 mmHg and < 180 mmHg; patients undergoing washout from their previous antihypertension medication had to have a mean seated SBP <180 mmHg.
- At Visit 2/Single-blind run-in entry, all patients had to have a mean seated SBP ≥ 155 mmHg and < 180 mmHg.
- At Visit 3/Core double-blind treatment period entry, all patients had to have a mean seated SBP ≥ 145 mmHg and < 180 mmHg.
- Ability to communicate and comply with all study requirements including measuring their blood pressure at home, daily as instructed, using the home blood pressure monitor provided by the Sponsor.
- Female patients had to be post-menopausal for at least one year.
Who cannot join
- Severe hypertension (mean seated SBP ≥ 180 mmHg and/or a mean seated DBP ≥ 110 mmHg).
- History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma, etc.).
- Use of three or more antihypertensive drugs. Dual fixed dose combination therapy was considered as two antihypertensive drugs.
- Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those antihypertensive medications requiring tapering down (e.g. beta-blocker and/or clonidine) commencing with Visit 1.
- Known moderate or malignant retinopathy. Moderate was defined as retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof; malignant defined as signs of moderate retinopathy plus swelling of the optic disk.
- Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers (ARB), calcium channel blockers (CCB), or to drugs with similar chemical structures.
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- History of cerebrovascular accident, thrombotic stroke, or transient ischemic attack.
- Significant history of coronary artery disease (CAD) such as any history of myocardial infarction (MI), angina pectoris, and all types of revascularization procedures.
- History of or diagnosis of congestive heart failure Grade II-IV according to the New York Heart Association (NYHA) classification.
- Clinically significant valvular heart disease.
- All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who, in the opinion of the investigator, were not well controlled. Patients who needed oral anti-diabetic medication to adequately control their Type 2 diabetes had to be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1.
- Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia.
- Second or third degree heart block with or without a pacemaker.
- Significant hepatic disease, as demonstrated by any one of the following: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than two times the upper limit of normal at Visit 1, a history of hepatic encephalopathy, a history of esophageal varices, or a history of a portocaval shunt.
- Evidence of renal impairment as determined by any one of the following: glomerular filtration rate (GFR) < 50 ml/min/1.73m2 as measured by the Modification of Diet in Renal Disease (MDRD) formula at Visit 1, a history of dialysis, or a history of nephrotic syndrome.
- History of clinically significant allergies including asthma and/or multiple drug allergies.
- Any surgical or medical condition with the potential to significantly alter the absorption, distribution, metabolism, or excretion of any drug including but not limited to any of the following: history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling, or gastric banding, currently active or inactive inflammatory bowel syndrome within 12 months prior to Visit 1, currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction regarded as clinically meaningful by the investigator.
- Any condition, not identified in the protocol, that, in the opinion of the investigator or the Novartis monitor, placed the patient at higher risk from his/her participation in the study, or was likely to prevent the patient from complying with the requirement of the study or completing the trial period.
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- Any chronic inflammatory condition needing chronic anti-inflammatory therapy.
- History of drug or alcohol abuse within the last 2 years.
- Use of investigational drugs at the time of enrollment, or within 30 days prior to Visit 1 (Week 8).
- Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent.
- Persons directly involved in the execution of this protocol.
- History of non-compliance to medical regimens, or patients unwilling to comply with the study protocol.
- Any severe, life-threatening disease within the past five years.
Trial locations and contacts
18 sites in 10 countries.
18 sites in 10 countries
Czechia6 sites
Novartis Investigative site
Brno
Investigative site Czech Republic
Chrudim
Investigative sites Czech Repbulic
Hodonín
Investigative site Czech Repbulic
Jičín
Sites in Czech Republic
Náchod
Investigative sites Czech Republic
Prague
Finland4 sites
Investigative site Finland
Helsinki
Investigative site Finland
Joensuu
Investigative site Finland
Kerava
Investigative site Finland
Tampere
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily
To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.
- Conditions
- Hypertension
- Being tested
- Amlodipine 5 mg, Valsartan 80 mg, Valsartan 40 mg, Placebo
- Keywords
- Blood pressure, hypertension, elderly
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amlodipine 5 mgDrug
1 capsule amlodipine 5 mg orally once daily
Valsartan 80 mgDrug
1 capsule valsartan 80 mg orally once daily
Valsartan 40 mgDrug
1 capsule valsartan 40 mg orally once daily
PlaceboDrug
1 capsule placebo to match valsartan orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine/Valsartan 5/80 mg | Experimental | 1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily Receives: Drug: Amlodipine 5 mg; Drug: Valsartan 80 mg |
| Amlodipine/Valsartan 5/40 mg | Active comparator | 1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily Receives: Drug: Amlodipine 5 mg; Drug: Valsartan 40 mg |
| Amlodipine 5 mg | Active comparator | 1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily Receives: Drug: Amlodipine 5 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)
At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
Measured: Baseline to end of study (Week 8)
Secondary outcomes (4)
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
Measured: Baseline to end of study (Week 8)
Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8
A systolic blood pressure response was defined as a msSBP < 140 mmHg or ≥ 15 mmHg reduction from baseline at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
Measured: Baseline to end of study (Week 8)
Percentage of Patients Achieving Systolic Blood Pressure Control at the End of the Study (Week 8)
Systolic blood pressure control was defined as a msSBP < 140 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
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 was defined as a msSBP < 140 mmHg and msDBP < 90 mmHg at the end of the study (Week 8). At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings.
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.
- First posted17 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2009
- Study completionMay 2009
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 965 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699192
- Sponsor's protocol ID
- CVAA489A2318
- Status last verified
- May 2011
- First submitted
- 9 Jun 2008
- Last updated
- 6 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of Once Daily Amlodipine/Valsartan 5/80 mg as Compared to Amlodipine/Valsartan 5/40 mg or to Amlodipine 5 mg Once Daily in Elderly Patients With Essential Hypertension Not Adequately Controlled After Four Weeks on Amlodipine 5 mg Once Daily
- ClinicalTrials.gov ID
- NCT00699192
- Acronym / sponsor ID
- CVAA489A2318
- Conditions
- Hypertension
- Keywords
- Blood pressure, hypertension, elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 965 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Posted 6 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To characterize the safety, tolerability, and efficacy profile of amlodipine/valsartan 5/80 mg as compared to amlodipine/valsartan 5/40 mg (with optional titration to 5/80 mg) and amlodipine 5 mg monotherapy in elderly patients (≥ 65 years of age) with essential hypertension. All three regimens are expected to be well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amlodipine/Valsartan 5/80 mg | Experimental | Drug: Amlodipine 5 mg, Drug: Valsartan 80 mg1 capsule amlodipine 5 mg, 1 capsule valsartan 80 mg once daily |
| Amlodipine/Valsartan 5/40 mg | Active comparator | Drug: Amlodipine 5 mg, Drug: Valsartan 40 mg1 capsule amlodipine 5 mg, 1 capsule valsartan 40 mg once daily |
| Amlodipine 5 mg | Active comparator | Drug: Amlodipine 5 mg, Drug: Placebo1 capsule amlodipine 5 mg, 1 capsule placebo to match valsartan once daily |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent before any assessment was performed.
- Male or female at least 65 years of age.
- Diagnosed as having hypertension:
- Ability to communicate and comply with all study requirements including measuring their blood pressure at home, daily as instructed, using the home blood pressure monitor provided by the Sponsor.
- Female patients had to be post-menopausal for at least one year.
Key exclusion criteria (26 listed)
- Severe hypertension (mean seated SBP ≥ 180 mmHg and/or a mean seated DBP ≥ 110 mmHg).
- History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma, etc.).
- Use of three or more antihypertensive drugs. Dual fixed dose combination therapy was considered as two antihypertensive drugs.
- Administration of any agent indicated for the treatment of hypertension after Visit 1, with the permitted exception of those antihypertensive medications requiring tapering down (e.g. beta-blocker and/or clonidine) commencing with Visit 1.
- Known moderate or malignant retinopathy. Moderate was defined as retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof; malignant defined as signs of moderate retinopathy plus swelling of the optic disk.
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 |
|---|---|---|
| Amlodipine 5 mg1 capsule amlodipine 5 mg orally once daily | Drug | Amlodipine 5 mg, Amlodipine/Valsartan 5/40 mg, Amlodipine/Valsartan 5/80 mg |
| Valsartan 80 mg1 capsule valsartan 80 mg orally once daily | Drug | Amlodipine/Valsartan 5/80 mg |
| Valsartan 40 mg1 capsule valsartan 40 mg orally once daily | Drug | Amlodipine/Valsartan 5/40 mg |
| Placebo1 capsule placebo to match valsartan orally once daily | Drug | Amlodipine 5 mg |
Primary outcome
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)
At study entry, blood pressure (BP) was measured in both arms with an automatic BP monitor. The arm with the higher systolic BP reading was used for all measurements throughout the study. At each study visit, 3 separate sitting BPs were obtained 23-26 hours post-dose with at least 2 minutes between measurements and with the cuff fully deflated. Mean BP was automatically calculated from the 3 readings. A negative change from baseline indicates lowered BP.
4 secondary outcomes
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)
Percentage of Patients Achieving a Systolic Blood Pressure Response at Week 8
Time frame: Baseline to end of study (Week 8)
Percentage of Patients Achieving Systolic 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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 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 Pharmaceuticals study director
Novartis Pharmaceuticals
18 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amlodipine 5 mg, Valsartan 80 mg and Valsartan 40 mg in people with Hypertension, run by Novartis Pharmaceuticals at 18 sites in 10 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 8 inclusion and 26 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 6 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Czechia, Finland, France, Germany, Hungary and 5 more countries. 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 6 Jun 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 Systolic Blood Pressure (msSBP) 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?
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 6 Jun 2011.