HypertensionPhase 3NCT02651870
Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
A Phase 3 study testing Candesartan 16mg, Amlodipine 5mg and Amlodipine 10mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Candesartan 16mg, Amlodipine 5mg and Amlodipine 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Apr 2015to 29 Feb 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 19 or above
- Inadequately controlled Essential hypertension at Screening
- Drug naive or didn't take antihypertensive drug within 2 weeks prior to Visit 1
- Mean sitDBP ≥ 95mmHg on target arm
- Taking antihypertensive drug but not controlled
- Mean sitDBP ≥ 90mmHg on target arm
Show all 9Show fewer
- Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy
- Mean sitDBP at Visit 2 ≥ 90mmHg on target arm
- Ability to provide written informed consent
Who cannot join
- The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
- Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2
- Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- Patient with congestive heart failure(NYHA class III, IV)
- Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 months
- History of stroke, cerebral hemorrhage within 6 months
Show all 20Show fewer
- Type I Diabetes mellitus, Type II Diabetes mellitus with HbA1c > 8.5%
- History of severe or malignant retinopathy
- AST/ALT > UNL*3, Serum creatinine > UNL*1.5, K > 5.5mEq/L
- Patient with acute or chronic inflammatory(treatment required) status
- Patient who need to take antihypertensive drug besides Investigational products
- Patient must be treated with medications prohibited for concomitant use during the study period
- History of angioedema related to ACE inhibitor or angiotensin II receptor blockers
- Hypersensitive to Candesartan/Amlodipine
- Patient who are dependent on drugs or alcohol within 6 months
- History of disability to drug ADME, active inflammatory bowel syndrome within 12months, impaired pancreatic function, GI bleeding, obstructions of urinary tract
- Patients treated with other investigational product within 30 days at first time taking the investigational product
- Women with pregnant, breast-feeding
- History of malignant tumor within 5 years
- Not eligible to participate for the study at the discretion of investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
- Conditions
- Hypertension
- Being tested
- Candesartan 16mg, Amlodipine 5mg, Amlodipine 10mg
- 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.
Candesartan 16mgDrug
Amlodipine 5mgDrug
Amlodipine 10mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Candesartan 16mg + Amlodipine 5mg | Experimental | Candesartan 16mg + Amlodipine 5mg, po, q.d. Receives: Drug: Candesartan 16mg; Drug: Amlodipine 5mg |
| Candesartan 16mg + Amlodipine 10mg | Experimental | Candesartan 16mg + Amlodipine 10mg, po, q.d. Receives: Drug: Candesartan 16mg; Drug: Amlodipine 10mg |
| Candesartan 16mg | Active comparator | Candesartan 16mg, po, q.d. Receives: Drug: Candesartan 16mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change of sitDBP(sitting diastolic blood pressure)
Measured: From baseline at week 8
Secondary outcomes (4)
The mean change of sitDBP
Measured: From baseline to week 4
The mean change of sitSBP
Measured: From baseline to week 4 and 8
Control rate: Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg
Measured: From baseline to week 8
Response rate: sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg
Measured: From baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start22 Apr 2015
- Primary completion25 Feb 2016
- Study completion29 Feb 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.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651870
- Sponsor's protocol ID
- 144HT14020
- Status last verified
- Aug 2020
- First submitted
- 8 Jan 2016
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
- ClinicalTrials.gov ID
- NCT02651870
- Acronym / sponsor ID
- 144HT14020
- Conditions
- Hypertension
- Keywords
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2015 (actual)
- Primary completion
- 25 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 11 Jan 2016 (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.
A Phase 3 Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Candesartan and Amlodipine Versus Candesartan Monotherapy in Hypertensive Patients Inadequately Controlled by Candesartan Monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Candesartan 16mg + Amlodipine 5mg | Experimental | Drug: Candesartan 16mg, Drug: Amlodipine 5mgCandesartan 16mg + Amlodipine 5mg, po, q.d. |
| Candesartan 16mg + Amlodipine 10mg | Experimental | Drug: Candesartan 16mg, Drug: Amlodipine 10mgCandesartan 16mg + Amlodipine 10mg, po, q.d. |
| Candesartan 16mg | Active comparator | Drug: Candesartan 16mgCandesartan 16mg, po, q.d. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of 19 or above
- Inadequately controlled Essential hypertension at Screening
- Inadequately controlled after 4 weeks of Candesartan 16mg monotherapy
- Ability to provide written informed consent
Key exclusion criteria (20 listed)
- The change of mean sitDBP ≥ 10mmHg or mean sitSBP ≥ 20mmHg on target arm at Visit 1
- Mean sitDBP ≥ 120mmHg or mean sitSBP ≥ 200mmHg on target arm at Visit 1 and Visit 2
- Known to suspected Stage 2 Hypertension(aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- Patient with congestive heart failure(NYHA class III, IV)
- Patient with unstable angina pectoris, myocardial infarction, Valvular heart disease, arrhythmia(treatment required) within 3 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 |
|---|---|---|
| Candesartan 16mg | Drug | Candesartan 16mg, Candesartan 16mg + Amlodipine 10mg, Candesartan 16mg + Amlodipine 5mg |
| Amlodipine 5mg | Drug | Candesartan 16mg + Amlodipine 5mg |
| Amlodipine 10mg | Drug | Candesartan 16mg + Amlodipine 10mg |
Primary outcome
The mean change of sitDBP(sitting diastolic blood pressure)
Time frame: From baseline at week 8
4 secondary outcomes
The mean change of sitDBP
Time frame: From baseline to week 4
The mean change of sitSBP
Time frame: From baseline to week 4 and 8
Control rate: Patient achieving sitSBP < 140mmHg and sitDBP < 90mmHg
Time frame: From baseline to week 8
Response rate: sitSBP reduction ≥ 20mmHg and sitDBP reduction ≥ 10mmHg
Time frame: From baseline to week 8
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 25 Aug 2020.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Candesartan 16mg, Amlodipine 5mg and Amlodipine 10mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site 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 9 inclusion and 20 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
The mean change of sitDBP(sitting diastolic blood pressure) (time frame: From baseline at 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 Aug 2020.