HypertensionPhase 3NCT01970059
A Phase Ⅲ Study of Extended-Release Carvedilol Sulfate for the Treatment of Hypertension
A Phase 3 study testing Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in people with Hypertension, run by Jiangsu HengRui Medicine Co., Ltd. at 11 sites in China.
Trial summary
The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 11 sitesChina
- Study dates
- Oct 2013to Oct 2013
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or Females
- Aged from 18 to 70 years
- Had a history of essential hypertension
- Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg
Who cannot join
- Malignant hypertension
- Average sitting systolic blood pressure≧180mmHg
- Type 2 diabetes with hemoglobin A1c≥9%
- Type 1 diabetes
- New York Heart Association class Ⅱ-Ⅳ congestive heart-failure
- Unstable angina
Show all 16Show fewer
- Second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place
- Atrial fibrillation
- Bradycardia (<60 bpm, seated)
- Asthma or other obstructive pulmonary disease
- History of myocardial infarction
- Stroke in the 6 months before screening
- Known contraindications to β-adrenergic blocker therapy
- Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>3 times upper limit of normal
- Crea>2 times upper limit of normal
- Pregnancy or lactation
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Xuan Wu hospital affiliated to Capital Medical University
Beijing, 100053
- Recruiting
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, 11691777
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yun Zhang, Professor, 86 135731022060, yun-zhang@163.com
Yun Zhang, Professor
- Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu
- Recruiting
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
- Recruiting
Taizhou Hospital
Taizhou, Zhejiang
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
About this study
Official title: Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension
The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension
- Conditions
- Hypertension
- Being tested
- Extended-Release Carvedilol Sulfate, Sustained-release Metoprolol Succinate
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended-Release Carvedilol SulfateDrug
Sustained-release Metoprolol SuccinateDrug
| Study group | Role | What they receive |
|---|---|---|
| Extended-Release Carvedilol Sulfate | Experimental | 18-72mg/d,po Receives: Drug: Extended-Release Carvedilol Sulfate |
| Sustained-release Metoprolol Succinate | Active comparator | 47.5-190mg/d,po Receives: Drug: Sustained-release Metoprolol Succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8
Measured: Baseline and Week 8
Secondary outcomes (2)
Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8
Measured: Baseline and Week 8
Proportion of Patients With Sitting Systolic Blood Pressure <140 mm Hg and Sitting Diastolic Blood Pressure <90 mm Hg at Week 8
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2013 (estimated)
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 Jiangsu HengRui Medicine Co., Ltd.The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Zhang, Professor, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970059
- Sponsor's protocol ID
- KWDLEH2012
- Status last verified
- Oct 2013
- First submitted
- 22 Oct 2013
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT01970059
- Acronym / sponsor ID
- KWDLEH2012
- Conditions
- Hypertension
- Keywords
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2013 (estimated)
- First posted
- 25 Oct 2013 (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 aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended-Release Carvedilol Sulfate | Experimental | Drug: Extended-Release Carvedilol Sulfate18-72mg/d,po |
| Sustained-release Metoprolol Succinate | Active comparator | Drug: Sustained-release Metoprolol Succinate47.5-190mg/d,po |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or Females
- Aged from 18 to 70 years
- Had a history of essential hypertension
- Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg
Key exclusion criteria (16 listed)
- Malignant hypertension
- Average sitting systolic blood pressure≧180mmHg
- Type 2 diabetes with hemoglobin A1c≥9%
- Type 1 diabetes
- New York Heart Association class Ⅱ-Ⅳ congestive heart-failure
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 |
|---|---|---|
| Extended-Release Carvedilol Sulfate | Drug | Extended-Release Carvedilol Sulfate |
| Sustained-release Metoprolol Succinate | Drug | Sustained-release Metoprolol Succinate |
Primary outcome
Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8
Time frame: Baseline and Week 8
2 secondary outcomes
Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8
Time frame: Baseline and Week 8
Proportion of Patients With Sitting Systolic Blood Pressure <140 mm Hg and Sitting Diastolic Blood Pressure <90 mm Hg at Week 8
Time frame: Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
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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.
Yun Zhang, Professor principal investigator
Qilu Hospital of Shandong University
11 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 Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in people with Hypertension, run by Jiangsu HengRui Medicine Co., Ltd. at 11 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 25 Oct 2013. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Zhang, Professor (86 135731022060, yun-zhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8 (time frame: Baseline and 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 25 Oct 2013; AzTrials last refreshed its copy on 26 Oct 2026.