HypertensionPhase 4NCT01518855
Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension
A Phase 4 study testing Nifedipine (Adalat, BAYA1040), Amlodipine (Norvasc) and Diovan in people with Hypertension, run by Bayer at 4 sites in Japan.
Trial summary
The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nifedipine (Adalat, BAYA1040), Amlodipine (Norvasc) and Diovan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 4 sitesJapan
- Study dates
- Mar 2004to Apr 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:
- SBP>/=160mmHg or DBP>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure)
- SBP>/=150mmHg or DBP>/=95mmHg for patients with previous treatment by antihypertensive agents
Who cannot join
- Patients whose blood pressure on either day of Visit 1 or 2 is: SBP > 200mmHg or DBP > 120mmHg.
- Patients with secondary hypertension or hypertensive emergency such as malignant hypertension.
- Patients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study.
- Patients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study.
- Patients with uncontrolled diabetes (HbA1c >/=8%)
- Patients with bradycardia or tachycardia (<50 bpm, >/=100 bpm), arrhythmia such as atrioventricular block (second and third degree), sinoatrial block or atrial fibrillation.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Hiroshima, Hiroshima, 733-0011
Study site
Sapporo, Hokkaido, 060-0003
Study site
Setagaya-ku, Tokyo, 158-0097
Study site
Shinjuku-ku, Tokyo, 163-6003
About this study
Official title: Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)
The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients.
To investigate incremental cost effectiveness, primary variables are mean treatment cost and achievement rate to target blood pressure level at the end of double-blind treatment period.
- Conditions
- Hypertension
- Being tested
- Nifedipine (Adalat, BAYA1040), Amlodipine (Norvasc), Diovan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine (Adalat, BAYA1040)Drug
Amlodipine (Norvasc)Drug
DiovanDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Adalat CR 20-40mg od + Diovan 40-80mg od Receives: Drug: Nifedipine (Adalat, BAYA1040); Drug: Diovan |
| Arm 2 | Active comparator | Norvasc 2.5-5mg od + Diovan 40-80mg od Receives: Drug: Amlodipine (Norvasc); Drug: Diovan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean treatment cost* for 16-week of double-blind treatment period
- Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores.
Measured: 16 weeks
Proportion of participants** achieving target blood pressure at the end of double-blind treatment period
**For subjects aged under 60 years: SBP<130mmHg and DBP<85mmHg, for subjects aged 60 years or over: SBP<140mmHg and DBP<90mmHg (SBP Systolic blood pressure, DBP Diastolic blood pressure)
Measured: at week 16
Secondary outcomes (5)
Treatment cost per subject to achieve the target blood pressure (Total costs for the double-blind treatment period / Number of patients who achieve the target blood pressure at the end of double-blind treatment period)
Measured: 16 weeks
The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .
Measured: baseline to week 16
Proportion of participants for each age group to target blood pressure level
Measured: at week 16
Incidence of treatment-emergent drug-related adverse events
Measured: 16 weeks
Safety variables will be summarized using descriptive statistics based on adverse events collections
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startMar 2004
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518855
- Sponsor's protocol ID
- 11518
- Status last verified
- Jan 2012
- First submitted
- 24 Jan 2012
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect and Cost Effectiveness of Ca Antagonist in Combination With AII Receptor Antagonist in Patient With Essential Hypertension (PMS Study)
- ClinicalTrials.gov ID
- NCT01518855
- Acronym / sponsor ID
- 11518
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients.
To investigate incremental cost effectiveness, primary variables are mean treatment cost and achievement rate to target blood pressure level at the end of double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Nifedipine (Adalat, BAYA1040), Drug: DiovanAdalat CR 20-40mg od + Diovan 40-80mg od |
| Arm 2 | Active comparator | Drug: Amlodipine (Norvasc), Drug: DiovanNorvasc 2.5-5mg od + Diovan 40-80mg od |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Untreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:
- SBP>/=160mmHg or DBP>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure)
- SBP>/=150mmHg or DBP>/=95mmHg for patients with previous treatment by antihypertensive agents
Key exclusion criteria (6 listed)
- Patients whose blood pressure on either day of Visit 1 or 2 is: SBP > 200mmHg or DBP > 120mmHg.
- Patients with secondary hypertension or hypertensive emergency such as malignant hypertension.
- Patients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study.
- Patients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study.
- Patients with uncontrolled diabetes (HbA1c >/=8%)
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 |
|---|---|---|
| Nifedipine (Adalat, BAYA1040) | Drug | Arm 1 |
| Amlodipine (Norvasc) | Drug | Arm 2 |
| Diovan | Drug | Arm 1, Arm 2 |
Primary outcome
Mean treatment cost* for 16-week of double-blind treatment period
Time frame: 16 weeks
* Including treatment cost for the drug related AEs. The sponsor will calculate the cost based on the tariff of health insurance scores.
Proportion of participants** achieving target blood pressure at the end of double-blind treatment period
Time frame: at week 16
**For subjects aged under 60 years: SBP<130mmHg and DBP<85mmHg, for subjects aged 60 years or over: SBP<140mmHg and DBP<90mmHg (SBP Systolic blood pressure, DBP Diastolic blood pressure)
5 secondary outcomes
Treatment cost per subject to achieve the target blood pressure (Total costs for the double-blind treatment period / Number of patients who achieve the target blood pressure at the end of double-blind treatment period)
Time frame: 16 weeks
The change in blood pressure (SBP and DBP) from the baseline (end of pretreatment period) .
Time frame: baseline to week 16
Proportion of participants for each age group to target blood pressure level
Time frame: at week 16
Incidence of treatment-emergent drug-related adverse events
Time frame: 16 weeks
Safety variables will be summarized using descriptive statistics based on adverse events collections
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
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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.
Bayer Study Director study director
Bayer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifedipine (Adalat, BAYA1040), Amlodipine (Norvasc) and Diovan in people with Hypertension, run by Bayer at 4 sites in Japan.
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 3 inclusion and 6 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 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean treatment cost* for 16-week of double-blind treatment period (time frame: 16 weeks). 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?
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 26 Jan 2012.