HypertensionPhase 3NCT02432937
Corever in the Treatment of Hypertension
A Phase 3 study testing Corever in people with Hypertension, run by TSH Biopharm Corporation Limited at 8 sites in Taiwan.
Trial summary
The study primarily aims to compare the effects of two doses of Corever with placebo in patients with hypertension. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Corever
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 8 sitesTaiwan
- Study dates
- Jan 2015to Aug 2016
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 20-90 years of age
- Patients who belong to either one of the following categories:
- With essential hypertension, as measured by office BP and are not on antihypertensive treatment at screening .
- With uncontrolled hypertension despite treatment with up to 2 antihypertensive agents, and the type and dose of the agents shall be maintained for at least 28 days prior to entering this trial.
- Agree to and are able to follow the study procedures.
- Understand the nature of the study, and have signed informed consent forms.
Who cannot join
- Patients with any of the following conditions:
- Malignant hypertension
- Secondary hypertension
- Average sitting SBP ≥ 180 mmHg
- Advanced hypertensive retinopathy
- Type 1 diabetes
Show all 25Show fewer
- Acute coronary syndrome
- Clinical significant valvular disease
- Hypertrophic cardiomyopathies
- New York Heart Association class III -IV congestive HF
- Second or third degree atrioventricular block or history of sick sinus syndrome unless a pacemaker is in place
- Atrial fibrillation
- Sinus bradycardia (<60 bpm)
- Asthma
- Stroke within 3 months
- Cancer with expected survival less than 3 years
- A difference of > 20 mmHg for SBP or > 10 mmHg for DBP between arms at screening
- Severe hepatic impairment
- A history of a serious hypersensitivity reaction.
- Patients with clinically significant abnormalities.
- Patients with known contraindication to Corever.
- Female patients who are pregnant or lactating.
- 5. Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study.
- Patients is currently participating in any other clinical trial within 30 days
- Patients need to be treated with the permitted medication.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Hualien Tzu Chi Hospital
Hualien City
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chung Shan Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase III Study of Corever for the Treatment of Hypertension
The study primarily aims to compare the effects of two doses of Corever with placebo in patients with hypertension.
Read the detailed description
The study aims to compare the effects of two doses of Corever with placebo in patients with essential hypertension. Eligible subjects who belong to one of the following subtypes are planned to be enrolled: (1) patients with essential hypertension without drug control, or (2) uncontrolled hypertension despite treatment with up to 2 antihypertensive agents. Of note, the second category will receive randomized study treatments in addition to continuing their previous medication throughout the trial. The study also wants to investigate the safety profile of Corever during treatment period.
- Conditions
- Hypertension
- Being tested
- Corever
- Keywords
- Corever, hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreverDrug
Also called CRTA04
Corever
| Study group | Role | What they receive |
|---|---|---|
| Corever middle dose | Placebo comparator | Not described Receives: Drug: Corever |
| Corever high dose | Placebo comparator | Not described Receives: Drug: Corever |
| Placebo | Placebo comparator | Not described Receives: Drug: Corever |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated Office SBP reduction (SBP each visit-SBP visit 2)
To compare the change in office SBP measurements by cuff assessments after 8 weeks of treatment
Measured: 8 weeks
Secondary outcomes (1)
Seated Office DBP reduction (DBP each visit-DBP visit 2)
- To compare the change in office DBP measurements by cuff assessments after 8 weeks of treatment
- To compare the percentage of subjects who achieve BP goal as measured by cuff assessments (140/90 mmHg) after 8 weeks of treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionAug 2016
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.
- 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- TSH Biopharm Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chern-En Chiang, M.D., Ph.D.,, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432937
- Sponsor's protocol ID
- TSHCR1201
- Status last verified
- Nov 2016
- First submitted
- 29 Jan 2015
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase III Study of Corever for the Treatment of Hypertension
- ClinicalTrials.gov ID
- NCT02432937
- Acronym / sponsor ID
- TSHCR1201
- Conditions
- Hypertension
- Keywords
- Corever, hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- TSH Biopharm Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 May 2015 (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 study primarily aims to compare the effects of two doses of Corever with placebo in patients with hypertension.
Detailed description
The study aims to compare the effects of two doses of Corever with placebo in patients with essential hypertension. Eligible subjects who belong to one of the following subtypes are planned to be enrolled: (1) patients with essential hypertension without drug control, or (2) uncontrolled hypertension despite treatment with up to 2 antihypertensive agents. Of note, the second category will receive randomized study treatments in addition to continuing their previous medication throughout the trial. The study also wants to investigate the safety profile of Corever during treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Corever middle dose | Placebo comparator | Drug: Corever |
| Corever high dose | Placebo comparator | Drug: Corever |
| Placebo | Placebo comparator | Drug: Corever |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are 20-90 years of age
- Patients who belong to either one of the following categories:
- With essential hypertension, as measured by office BP and are not on antihypertensive treatment at screening .
- With uncontrolled hypertension despite treatment with up to 2 antihypertensive agents, and the type and dose of the agents shall be maintained for at least 28 days prior to entering this trial.
- Agree to and are able to follow the study procedures.
Key exclusion criteria (25 listed)
- Patients with any of the following conditions:
- Patients with clinically significant abnormalities.
- Patients with known contraindication to Corever.
- Female patients who are pregnant or lactating.
- 5. Male or female patients of child-bearing potential who do not agree to use an effective method of contraception during the study.
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 |
|---|---|---|
| CoreverAlso: CRTA04Corever | Drug | Corever high dose, Corever middle dose, Placebo |
Primary outcome
Seated Office SBP reduction (SBP each visit-SBP visit 2)
Time frame: 8 weeks
To compare the change in office SBP measurements by cuff assessments after 8 weeks of treatment
1 secondary outcome
Seated Office DBP reduction (DBP each visit-DBP visit 2)
Time frame: 8 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 4 Nov 2016.
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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.
Chern-En Chiang, M.D., Ph.D., principal investigator
Taipei Veterans General Hospital, Taiwan
8 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 Corever in people with Hypertension, run by TSH Biopharm Corporation Limited at 8 sites in Taiwan.
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 25 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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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?
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?
Seated Office SBP reduction (SBP each visit-SBP visit 2) (time frame: 8 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 4 Nov 2016.