HypertensionPhase 3NCT00413049
Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension
A Phase 3 study testing Valsartan/amlodipine 80/5 mg and Amlodipine 5 mg in people with Hypertension, run by Novartis at 12 sites in China.
Trial summary
This study will evaluate 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 and Amlodipine 5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 698 participants
- Where
- 12 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 hypertension measured by calibrated mercury sphygmomanometer (preferred) or an aneroid device if a mercury sphygmomanometer was not available.
- At Visit 1, patients not treated with antihypertensive medications had to have a MSDBP of ≥ 95 mmHg and < 110 mmHg; those patients treated with antihypertensive medication had to have a MSDBP of < 110 mmHg.
- At Visit 2, patients must have a MSDBP of ≥ 95 mmHg but < 110 mmHg.
- At Visit 3, patients must have a MSDBP of ≥ 90 mmHg and < 110 mmHg.
- Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).
Who cannot join
- Severe hypertension (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 180 mmHg).
- In cases where the patient was on more than one antihypertensive drug whether in fixed or free combination, the investigator considered the efficacy and strength of each active ingredient in order to determine if the patient could be safely removed from their antihypertensive treatment.
- 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.
- Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that required tapering down.
- Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2, as required by the protocol.
- History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or all types of revascularization.
Show all 33Show fewer
- Malignant hypertension.
- All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who were not well controlled based on the investigator's clinical judgment. Patients being treated for diabetes mellitus had to have satisfactory metabolic control. Type 2 diabetic patients taking oral anti-diabetic medication had to be on a stable dose for at least 4 weeks prior to Visit 1.
- Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/ml).
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precluded intercourse with a male partner and women whose partners had been sterilized by vasectomy or other means, UNLESS they met the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/m or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy OR were using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), and double-barrier methods (any double combination of: intra-uterine device [IUD], male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable methods of contraception included total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensured compliance. Reliable contraception had to be maintained throughout the study and for 7 days after study drug discontinuation. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception. Hormonal contraceptive use was disallowed.
- History of heart failure Grade II-IV according to the New York Heart Association (NYHA) classification.
- Second or third degree heart block with or without a pacemaker.
- Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia.
- Angina pectoris of any type, including unstable angina pectoris.
- Clinically significant valvular heart disease.
- Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing disease, pheochromocytoma, polycystic kidney disease.
- Known moderate or malignant retinopathy, defined as: moderate (retinal signs of hemorrhage, microaneurysm, cotton-wool spot, hard exudates, or a combination thereof) or malignancy (signs of moderate retinopathy plus swelling of the optic disk).
- Evidence of hepatic disease as determined 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 anyone of the following: serum creatinine > 1.5 times the upper limit of normal 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 active 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 surgical or medical condition, which in the opinion of the investigator or the Novartis monitor, placed the patient at higher risk from his/her participation in the study, or were likely to prevent the patient from complying with the requirement of the study or completing the trial period.
- Volume depletion based on the investigator's clinical judgment using vital signs, skin turgor, moistness of mucous membranes, and laboratory values.
- Any chronic inflammatory condition requiring chronic anti-inflammatory therapy.
- 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.
- History of drug of alcohol abuse within the last 2 years.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever was longer.
- 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 unwillingness to comply with the study protocol.
- Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- Any severe, life-threatening disease within the past five years.
- Arm circumference > 42 cm for patients participating in ambulatory blood pressure monitoring (ABPM).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
China-Japan Friendship Hospital
Beijing, 100029
People's hospital affiliated Beijing University
Beijing, 100044
The third Xiangya hospital of central south University
Changsha, 410003
The first hospital affiliated the third military Medical University
Chongqing, 400038
The third hospital affiliated the third military Medical University
Chongqing, 400042
Union hospital affiliated Fujian medical University
Fuzhou, 350001
The first hospital affiliated Fujian medical University
Fuzhou, 350005
The second hospital affiliated Jiangxi medical school
Nanchang, 330006
Institute of Hypertension, Ruijin Hospital
Shanghai, 200025
Zhongshan hospital affiliated Fudan University
Shanghai, 200032
The sixth people's hospital of Shanghai
Shanghai, 200233
The first hospital affiliated school of medical of Xi'an Jiaotong University
Xi'an, 710061
About this study
Official title: A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Amlodipine 5 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Monotherapy
This study will evaluate 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, Amlodipine 5 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 and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
Amlodipine 5 mgDrug
1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
| Study group | Role | What they receive |
|---|---|---|
| Valsartan/amlodipine 80/5 mg | Experimental | Not described Receives: Drug: Valsartan/amlodipine 80/5 mg |
| Amlodipine 5 mg | Active comparator | Not described Receives: Drug: Amlodipine 5 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. A negative change score indicates lowered BP.
Measured: Baseline to end of study (Week 8)
Secondary outcomes (5)
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. A negative change score indicates lowered BP.
Measured: Baseline to end of study (Week 8)
Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)
A patient achieved a diastolic response if their msDBP < 90 mmHg at Week 8 or they had a ≥ 10 mmHg decrease in msDBP 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 Control at the End of the Study (Week 8)
A patient achieved diastolic control if their 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: Baseline to end of study (Week 8)
Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)
A patient achieved overall control if the 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: Baseline to end of study (Week 8)
Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)
Two 24 hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline prior to randomization and one at Week 8 (end of study), in a subset of the intent-to-treat population of patients. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient. A correlation was made between the ABPM device readings and measurements taken with a mercury sphygmomanometer and stethoscope. Following the correlation procedure, BP was measured at study specified intervals. A negative change score indicates lowered BP.
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.
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413049
- Sponsor's protocol ID
- CVAA489A2315
- Status last verified
- Apr 2011
- First submitted
- 18 Dec 2006
- Last updated
- 29 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ke Y, Zhu D, Hong H, Zhu J, Wang R, Cardenas P, Zhang Y. Efficacy and safety of a single-pill combination of amlodipine/valsartan in Asian hypertensive patients inadequately controlled with amlodipine monotherapy. Curr Med Res Opin. 2010 Jul;26(7):1705-13. doi: 10.1185/03007995.2010.487391.
PubMed 20469975
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-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Amlodipine 5 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Monotherapy
- ClinicalTrials.gov ID
- NCT00413049
- Acronym / sponsor ID
- CVAA489A2315
- Conditions
- Hypertension
- Keywords
- Hypertension, valsartan, amlodipine, high blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- NovartisIndustry (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 8 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan/amlodipine 80/5 mg | Experimental | Drug: Valsartan/amlodipine 80/5 mg |
| Amlodipine 5 mg | Active comparator | Drug: Amlodipine 5 mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female outpatients ≥ 18 years and < 86 years
- Patients with essential hypertension measured by calibrated mercury sphygmomanometer (preferred) or an aneroid device if a mercury sphygmomanometer was not available.
- At Visit 1, patients not treated with antihypertensive medications had to have a MSDBP of ≥ 95 mmHg and < 110 mmHg; those patients treated with antihypertensive medication had to have a MSDBP of < 110 mmHg.
- At Visit 2, patients must have a MSDBP of ≥ 95 mmHg but < 110 mmHg.
- At Visit 3, patients must have a MSDBP of ≥ 90 mmHg and < 110 mmHg.
Key exclusion criteria (33 listed)
- Severe hypertension (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 180 mmHg).
- In cases where the patient was on more than one antihypertensive drug whether in fixed or free combination, the investigator considered the efficacy and strength of each active ingredient in order to determine if the patient could be safely removed from their antihypertensive treatment.
- 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.
- Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that required tapering down.
- Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2, as required by the protocol.
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 and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures. | Drug | Valsartan/amlodipine 80/5 mg |
| Amlodipine 5 mg1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures. | Drug | Amlodipine 5 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. A negative change score indicates lowered BP.
5 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 Response at the End of the Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)
Time frame: Baseline to 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 29 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20469975Ke Y, Zhu D, Hong H, Zhu J, Wang R, Cardenas P, Zhang Y. Efficacy and safety of a single-pill combination of amlodipine/valsartan in Asian hypertensive patients inadequately controlled with amlodipine monotherapy. Curr Med Res Opin. 2010 Jul;26(7):1705-13. doi: 10.1185/03007995.2010.487391.
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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
12 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 and Amlodipine 5 mg in people with Hypertension, run by Novartis at 12 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 6 inclusion and 33 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 12 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 8 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 NCT00413049, which also lists 1 linked publication.
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.