HypertensionNCT02336607
The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release in Chinese Patients.
A study testing Felodipine tablet (Plendil) alone, Felodipine tablet (Plendil)+Hydrochlorothiazide and Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK) in people with Hypertension, run by AstraZeneca.
Trial summary
The purpose of this study is to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in Chinese Hypertension patients. Read more about this study
- Who is it for?
- Ages 35 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Felodipine tablet (Plendil) alone, Felodipine tablet (Plendil)+Hydrochlorothiazide and Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 529 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Aug 2006
- Phase
- Interventional
- 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 35 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Female or male aged between 35-79 years old
- Mild to moderate essential hypertension patients who meet any of the following criterias:
- Newly diagnosed, drug-naive, or without any antihypertension treatment for at least 3 months, moderate essential hypertension patients. (160mmHg mean SiSBP 180mmHg or 100mmHg mean SiDBP 110mmHg)
- Newly diagnosed, drug-naive, or without any antihypertension treatment for at least 3 months, mild essential hypertension patients (140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg) with high or extreme high cardiovascular risk (a)(having 3 or more than 3 risk factors and/or target organ lesion and/or diabetes mellitus).
- according to Chinese guideline for prevention and treatment of patients with hypertension 2004.
Show all 10Show fewer
- The patients have already received starting dosage of single anti-hypertension drug therapy (exclude the drugs containing felodipine component ), however the blood pressure is not well controlled (140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg). After stopping the drug for 5 eliminating half life time, the patients meet any one of the following two:
- 160mmHg mean SiSBP 180mmHg or 100mmHg mean SiDBP 110mmHg.
- 140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg) with high or extreme high cardiovascular risk* (having 3 or more than 3 risk factors and/or target organ lesion and/or diabetes mellitus).
- Sitting blood pressure is taken after subjects take a seat to rest for 5 minutes before the next medication.
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- Known or suspected secondary hypertension
- Resting heart rate is < 55bpm.
- Sick sinus syndrome
- Atrioventricular block of first degree (with P-R>0.24seconds), or second or third degree
- Other clinical significant arrhythmia
Show all 19Show fewer
- Unstable and/or decompensated congestive heart failure
- Angina, acute myocardial infarction, percutaneous coronary intervention (PCI), or cardiac surgery
- Asthma or moderate to severe chronic obstructive pulmonary disease
- Type 1 diabetes mellitus
- Gout history
- Fasting serum glucose of greater than 200 mg/dl (11.1 mmol/L) or type 2 diabetes mellitus needs insulin therapy
- ALT>3ULN
- Cr>1.5mg/dl
- Pregnancy or lactation.
- Alcohol or drug abuse
- Known need for other concomitant anti-hypertensive therapy during the study besides the study drug.
- Known or suspected allergy to investigational drug or non-active ingredients of investigational drugs, known allergy to other blockers, calcium antagonist, diuretics, angiotensin converting enzyme inhibitor or with other contraindications.
- Suspected white-coat hypertension based on investigator's judgement.
About this study
Official title: A Randomized, Open-label Study to Evaluate the Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release, Alone and in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide, in Chinese Patients With Mild to Moderate Essential Hypertension.
The purpose of this study is to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in Chinese Hypertension patients.
Read the detailed description
In this study, investigators will choose male and female subjects aged between 35 and 79 years old with mild to moderate essential hypertension. At first 2 weeks, all patients will use felodipine 5mg daily. If the blood pressure dosen't meet the target (140/90mmHg), they will be randomized into metoprolol, lisinopril or hydrochlorothiazide combination groups for another 4 weeks therapy. After that, if the blood pressure has still not met the target, up-titrate the felodipine into 10mg, followed by a 4 weeks therapy. And if the blood pressure is still not met the target after that, up-titrate the combine drugs into maximum dosage. The whole treatment duration is 14 weeks.
The primary outcome is to evaluate the percentage of subjects reaching blood pressure target (defined as < 140 / 90 mmHg) after 14 weeks treatment with felodipine sustained release in combination with metoprolol, lisinopril or hydrochlorothiazide.
- Conditions
- Hypertension
- Being tested
- Felodipine tablet (Plendil) alone, Felodipine tablet (Plendil)+Hydrochlorothiazide, Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK), Felodipine tablets (Plendil)+Lisinopril (Zestril)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Felodipine tablet (Plendil) aloneDrug
Felodipine sustained release tablet single drug therapy (1st week- 2nd week) Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is controlled after 2 weeks, then the subjects will continue the treatment until the end of primary therapy stage (14th week).
Felodipine tablet (Plendil)+HydrochlorothiazideDrug
Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks.
If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with hydrochlorothiazide 12.5mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled.
Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)Drug
Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks.
If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with metoprolol succinate prolonged-release tablet (Betaloc ZOK) 47.5mg , once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled.
Felodipine tablets (Plendil)+Lisinopril (Zestril)Drug
Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks.
If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with Lisinopril (Zestril) 10mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled.
| Study group | Role | What they receive |
|---|---|---|
| Felodipine tablet (Plendil) | Experimental | Not described Receives: Drug: Felodipine tablet (Plendil) alone |
| Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK) | Active comparator | Not described Receives: Drug: Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK) |
| Felodipine tablets (Plendil)+Lisinopril (Zestril) | Active comparator | Not described Receives: Drug: Felodipine tablets (Plendil)+Lisinopril (Zestril) |
| Felodipine tablet (Plendil)+Hydrochlorothiazide | Active comparator | Not described Receives: Drug: Felodipine tablet (Plendil)+Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Measured: 14 weeks
Secondary outcomes (11)
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Measured: 4 weeks
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Measured: 8 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Measured: 4 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Measured: 8 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Measured: 12 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.
Measured: 4 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.
Measured: 8 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.
Measured: 12 weeks
The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.
Measured: 12 weeks
The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.
The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.
Measured: 12 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone
The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startDec 2005
- Primary completionJun 2006
- Study completionAug 2006
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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ningling Sun, PhD, MD, Principal investigator, Beijing University People's Hospital, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336607
- Sponsor's protocol ID
- D4385L00001
- Status last verified
- Mar 2015
- First submitted
- 25 Nov 2014
- Last updated
- 23 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study to Evaluate the Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of Felodipine Sustained Release, Alone and in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide, in Chinese Patients With Mild to Moderate Essential Hypertension.
- ClinicalTrials.gov ID
- NCT02336607
- Acronym / sponsor ID
- D4385L00001
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 23 Mar 2015
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 evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in Chinese Hypertension patients.
Detailed description
In this study, investigators will choose male and female subjects aged between 35 and 79 years old with mild to moderate essential hypertension. At first 2 weeks, all patients will use felodipine 5mg daily. If the blood pressure dosen't meet the target (140/90mmHg), they will be randomized into metoprolol, lisinopril or hydrochlorothiazide combination groups for another 4 weeks therapy. After that, if the blood pressure has still not met the target, up-titrate the felodipine into 10mg, followed by a 4 weeks therapy. And if the blood pressure is still not met the target after that, up-titrate the combine drugs into maximum dosage. The whole treatment duration is 14 weeks.
The primary outcome is to evaluate the percentage of subjects reaching blood pressure target (defined as < 140 / 90 mmHg) after 14 weeks treatment with felodipine sustained release in combination with metoprolol, lisinopril or hydrochlorothiazide.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Felodipine tablet (Plendil) | Experimental | Drug: Felodipine tablet (Plendil) alone |
| Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK) | Active comparator | Drug: Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK) |
| Felodipine tablets (Plendil)+Lisinopril (Zestril) | Active comparator | Drug: Felodipine tablets (Plendil)+Lisinopril (Zestril) |
| Felodipine tablet (Plendil)+Hydrochlorothiazide | Active comparator | Drug: Felodipine tablet (Plendil)+Hydrochlorothiazide |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of written informed consent
- Female or male aged between 35-79 years old
- Mild to moderate essential hypertension patients who meet any of the following criterias:
- Sitting blood pressure is taken after subjects take a seat to rest for 5 minutes before the next medication.
Key exclusion criteria (19 listed)
- Known or suspected secondary hypertension
- Resting heart rate is < 55bpm.
- Sick sinus syndrome
- Atrioventricular block of first degree (with P-R>0.24seconds), or second or third degree
- Other clinical significant arrhythmia
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 |
|---|---|---|
| Felodipine tablet (Plendil) aloneFelodipine sustained release tablet single drug therapy (1st week- 2nd week) Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is controlled after 2 weeks, then the subjects will continue the treatment until the end of primary therapy stage (14th week). | Drug | Felodipine tablet (Plendil) |
| Felodipine tablet (Plendil)+HydrochlorothiazideStep 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with hydrochlorothiazide 12.5mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled. | Drug | Felodipine tablet (Plendil)+Hydrochlorothiazide |
| Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with metoprolol succinate prolonged-release tablet (Betaloc ZOK) 47.5mg , once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled. | Drug | Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK) |
| Felodipine tablets (Plendil)+Lisinopril (Zestril)Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with Lisinopril (Zestril) 10mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled. | Drug | Felodipine tablets (Plendil)+Lisinopril (Zestril) |
Primary outcome
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 14 weeks
11 secondary outcomes
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 4 weeks
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 8 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 4 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 8 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 12 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 4 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 8 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 12 weeks
The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.
Time frame: 12 weeks
The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.
Time frame: 12 weeks
The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- CSR-D4385L00001.pdfLink provided by the sponsor.
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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.
Ningling Sun, PhD, MD principal investigator
Beijing University People's Hospital, Department of Cardiology
Questions about this trial
What is this clinical trial studying?
A study testing Felodipine tablet (Plendil) alone, Felodipine tablet (Plendil)+Hydrochlorothiazide and Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK) in people with Hypertension, run by AstraZeneca.
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 10 inclusion and 19 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 23 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2015). 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?
The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide. (time frame: 14 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 23 Mar 2015.