HypertensionPhase 4NCT00348686
Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)
A Phase 4 study testing Candesartan and Felodipine in people with Hypertension and Left Ventricular Hypertrophy, run by AstraZeneca at 11 sites in South Korea.
Trial summary
The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Left Ventricular Hypertrophy
- What is being tested?
- Candesartan and Felodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Jun 2006to Jun 2008
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension with diastolic blood pressure within 95-115 mm/Hg or/and systolic blood pressure within 160-200 mm/Hg
- Patients diagnosed as left ventricular hypertrophy by electrocardiogram
Who cannot join
- Secondary hypertension
- History of myocardial infarction
- Stroke within the previous 6 months
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Research Site
Busan
Research Site
Cheonan
Research Site
Cheongju-si
Research Site
Chunbuk
Research Site
Daegu
Research Site
Daejeon
Research Site
Gyungsangnamdo
Research Site
Jeonju
Research Site
Kwangju
Research Site
Pusan
Research Site
Ulsan
About this study
Official title: A Multicenter, Non-comparative, Phase IV Study to Evaluate the Effect of Candesartan Based Therapy in the Percent Change of proBNP Level After 24 Week Treatment in the Patients With Hypertension With Left Ventricular Hypertrophy
The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy.
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Being tested
- Candesartan, Felodipine
- Keywords
- LVH
- Medical subject headings
- Hypertension, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
Also called Atacand
16 mg once daily in oral tablet form
CandesartanDrug
Also called Antacand
32 mg once daily in oral tablet form
FelodipineDrug
5 mg once daily in oral tablet form
FelodipineDrug
10 mg once daily in oral tablet form
| Study group | Role | What they receive |
|---|---|---|
| Candesartan | Experimental | Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures. Receives: Drug: Candesartan; Drug: Felodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change of B Type Natriuretic Peptides (BNP) Level
Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.
Measured: At Baseline and 24 weeks
Secondary outcomes (5)
LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index
Change of Left Ventricular Hypertrophy(LVH) by Echocardiac Parameter, Left Ventricular mass Index (LVMI) was calculated and collected through the way of Last Observational carried forward. LVH/Index was calculated like this: Divide LV mass with Body Surface Area.
Measured: At Baseline and 24 weeks
Change of Systolic Blood Pressure (SBP)
Change of Systolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.
Measured: At Baseline and 24 weeks
Change of Diastolic Blood Pressure (DBP)
Change of Diastolic Blood Pressure was calculated and collected through the way of Last Observational carried forward.
Only who has diastolic blood pressure data both baseline and follow up was analyzed. Most of patient who enrolled, 302 have a data.
Measured: At Baseline and 24 weeks
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only
Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.
Measured: At Baseline and 24 weeks
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine
Percent change of proBNP(B type Natriuretic Peptides) was calculated and collected through the way of Last Observational carried forward.
Measured: At Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2008
- Study completionJun 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 HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JeeWoong Son, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348686
- Sponsor's protocol ID
- D2452L00012
- Other IDs
- CAP
- Status last verified
- Mar 2012
- First submitted
- 3 Jul 2006
- Last updated
- 2 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-comparative, Phase IV Study to Evaluate the Effect of Candesartan Based Therapy in the Percent Change of proBNP Level After 24 Week Treatment in the Patients With Hypertension With Left Ventricular Hypertrophy
- ClinicalTrials.gov ID
- NCT00348686
- Acronym / sponsor ID
- D2452L00012
- Conditions
- Hypertension, Left Ventricular Hypertrophy
- Keywords
- LVH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Jul 2006 (estimated)
- Results
- Posted 2 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candesartan | Experimental | Drug: Candesartan, Drug: FelodipineSubjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hypertension with diastolic blood pressure within 95-115 mm/Hg or/and systolic blood pressure within 160-200 mm/Hg
- Patients diagnosed as left ventricular hypertrophy by electrocardiogram
Key exclusion criteria (3 listed)
- Secondary hypertension
- History of myocardial infarction
- Stroke within the previous 6 months
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 |
|---|---|---|
| CandesartanAlso: Atacand16 mg once daily in oral tablet form | Drug | Candesartan |
| CandesartanAlso: Antacand32 mg once daily in oral tablet form | Drug | Candesartan |
| Felodipine5 mg once daily in oral tablet form | Drug | Candesartan |
| Felodipine10 mg once daily in oral tablet form | Drug | Candesartan |
Primary outcome
Percent Change of B Type Natriuretic Peptides (BNP) Level
Time frame: At Baseline and 24 weeks
Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.
5 secondary outcomes
LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index
Time frame: At Baseline and 24 weeks
Change of Systolic Blood Pressure (SBP)
Time frame: At Baseline and 24 weeks
Change of Diastolic Blood Pressure (DBP)
Time frame: At Baseline and 24 weeks
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only
Time frame: At Baseline and 24 weeks
Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine
Time frame: At Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
- 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.
JeeWoong Son, MD study director
AstraZeneca
11 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 Candesartan and Felodipine in people with Hypertension and Left Ventricular Hypertrophy, run by AstraZeneca at 11 sites in South Korea.
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 2 inclusion and 3 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 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. 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?
Yes. Results are posted in the registry (first posted 2 Apr 2012). 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?
Percent Change of B Type Natriuretic Peptides (BNP) Level (time frame: At Baseline and 24 weeks). 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 2 Apr 2012; AzTrials last refreshed its copy on 1 Nov 2026.