Chronic HypertensionPhase 1NCT01403922
To Determine Blood Pressure Interaction Between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors) in Patients With Chronic Hypertension
A Phase 1 study testing TC-5214 in people with Chronic Hypertension, run by AstraZeneca at 4 sites in 3 countries.
Trial summary
This is a two part study. Part 1 will determine determine if administration of TC-5214 has an effect on sitting blood pressure in patients with chronic hypertension. Part 2 will determine any possible interactions between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hypertension
- What is being tested?
- TC-5214
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Aug 2011to Aug 2012
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Male or female patients with chronic, stable hypertension treated for at least 1 month before screening with a calcium channel blocker, a beta blocker, or an ACE inhibitor, either as the only anti-hypertensive medication or concurrently with a diuretic. The patients should have no change in their current anti hypertensive treatment for at least 1 month before dosing
- Patients in Part 1 should have an SBP of ≤140 mmHg at screening and ≤160 mmHg at Visit 1a and pre-dose on Day 1
- Patients in Part 2 should have an SBP of ≤160 mmHg at screening Visit 1 and pre dose on Day 1. Systolic blood pressure and DBP should not vary by more than 8 mmHg and 5 mmHg, respectively, in the pre-dose period (screening, Visit 1a, and pre-dose on Day 1)
- Age 18 to 65 years (inclusive)
Who cannot join
- Other than having chronic hypertension, the history of any clinically significant medical, neurologic, or psychiatric disease or disorder which, in the opinion of the Investigator and/or the Sponsor, may either put the patient at risk because of participation in the study or influence the results, or the patient's ability to participate in the study. Patients with dyslipidaemia (diet controlled or treated with a statin) and/or metabolic syndrome (diet controlled or treated with metformin) may be entered into the study
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
- Patients with a pre-treatment SBP (if known) of >180 mmHg or a history of accelerated or malignant hypertension based on grade III (hypertensive haemorrhages and/or cotton wool spots) or grade IV (hypertensive papilloedema) retinopathy at any time
- History or presence of gastrointestinal (including irritable bowel disease), hepatic, or renal disease (creatinine clearance of ≤50 mL/minute calculated using the Cockcroft Gault equation) or any other condition known to interfere with the ADME of the investigational product.
- Patients with a history of surgery on the gastrointestinal tract (not including appendectomy or cholecystectomy) should also be excluded
- Any significant ECG abnormality including QTcF prolongation (>450 ms) or significant arrhythmias, or junctional rhythms
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Research Site
Overland Park, Kansas
Research Site
Willingboro, New Jersey
About this study
Official title: A Phase I Randomised, Placebo-Controlled, Double-Blind Study in Hypertensive Patients of the Blood Pressure Interaction Between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors)
This is a two part study. Part 1 will determine determine if administration of TC-5214 has an effect on sitting blood pressure in patients with chronic hypertension.
Part 2 will determine any possible interactions between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors).
Read the detailed description
A Phase I Randomised, Placebo-Controlled, Double-Blind Study in Hypertensive Patients of the Blood Pressure Interaction between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors)
- Conditions
- Chronic Hypertension
- Being tested
- TC-5214
- Keywords
- Phase I, Randomised, Placebo-Controlled, Double-Blind,Hypertensive Patients, Blood Pressure, Calcium Channel Blockers, Beta Blockers, ACE Inhibitors, Scientific terminology: To determine if treatment with TC5214 alone or in combination with Anti-Hypertensive Medications has an effect on sitting blood pressure, Laymen terminology: Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-5214Drug
Tablet oral bid days 1 to 7
TC-5214Drug
Tablet oral bid days 8 to 14
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TC-5214 Receives: Drug: TC-5214 |
| 2 | Experimental | TC-5214 with placebo Receives: Drug: TC-5214 |
| 3 | Experimental | TC-5214 with placebo Receives: Drug: TC-5214 |
| 4 | Experimental | TC-5214 Receives: Drug: TC-5214 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: To measure the effect of TC-5214 on sitting blood pressure in patients with chronic hypertension.
The following assessments will be measured and reported:
- A change from baseline in blood pressure and pulse rate.
Measured: Day 1 through to follow up
Part 2: To measure the effect of TC-5214 combined with treatment with the common classes of anti-hypertensive medication (calcium channel blockers, beta blockers, angiotensin converting enzyme inhibitors) on sitting blood pressure.
The following assessments will be measured and reported:
A change from baseline in blood pressure and pulse rate.
Measured: Day 1 through to follow up
Secondary outcomes (2)
To examine the safety and tolerability of TC-5214.
The following assessments will be measured and reported:
- The number of particpants with adverse events
- A change from baseline in blood pressure and pulse rate
- A change from baseline in laboratory assessments
- A change from baseline in vital signs
- A change from baseline in electrocardiogram (ECG)
- A change from baseline in physical examination
Measured: Day 1 through to Follow up
The concentration of TC-5214 in plasma will be measured.
Measured: Day 1 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Sponsor's decision to terminate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans A Eriksson, MD, PhD, MBA, Study director, AstraZeneca PharmaceuticalsKvarnbergagatan 12, 15185, Sodertalje, SwedenJames Ritter, MD,FRCP FFPM, Principal investigator, Quintiles Drug Research Unit at Guy's HospitalQuintiles Limited6 Newcomen StreetLondon SE1 1YR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403922
- Sponsor's protocol ID
- D4130C00010
- Status last verified
- Oct 2012
- First submitted
- 26 Jul 2011
- Last updated
- 2 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomised, Placebo-Controlled, Double-Blind Study in Hypertensive Patients of the Blood Pressure Interaction Between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors)
- ClinicalTrials.gov ID
- NCT01403922
- Acronym / sponsor ID
- D4130C00010
- Conditions
- Chronic Hypertension
- Keywords
- Phase I, Randomised, Placebo-Controlled, Double-Blind,Hypertensive Patients, Blood Pressure, Calcium Channel Blockers, Beta Blockers, ACE Inhibitors, Scientific terminology: To determine if treatment with TC5214 alone or in combination with Anti-Hypertensive Medications has an effect on sitting blood pressure, Laymen terminology: Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision to terminate
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Jul 2011 (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.
This is a two part study. Part 1 will determine determine if administration of TC-5214 has an effect on sitting blood pressure in patients with chronic hypertension.
Part 2 will determine any possible interactions between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors).
Detailed description
A Phase I Randomised, Placebo-Controlled, Double-Blind Study in Hypertensive Patients of the Blood Pressure Interaction between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TC-5214TC-5214 |
| 2 | Experimental | Drug: TC-5214TC-5214 with placebo |
| 3 | Experimental | Drug: TC-5214TC-5214 with placebo |
| 4 | Experimental | Drug: TC-5214TC-5214 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific procedures
- Male or female patients with chronic, stable hypertension treated for at least 1 month before screening with a calcium channel blocker, a beta blocker, or an ACE inhibitor, either as the only anti-hypertensive medication or concurrently with a diuretic. The patients should have no change in their current anti hypertensive treatment for at least 1 month before dosing
- Patients in Part 1 should have an SBP of ≤140 mmHg at screening and ≤160 mmHg at Visit 1a and pre-dose on Day 1
- Patients in Part 2 should have an SBP of ≤160 mmHg at screening Visit 1 and pre dose on Day 1. Systolic blood pressure and DBP should not vary by more than 8 mmHg and 5 mmHg, respectively, in the pre-dose period (screening, Visit 1a, and pre-dose on Day 1)
- Age 18 to 65 years (inclusive)
Key exclusion criteria (6 listed)
- Other than having chronic hypertension, the history of any clinically significant medical, neurologic, or psychiatric disease or disorder which, in the opinion of the Investigator and/or the Sponsor, may either put the patient at risk because of participation in the study or influence the results, or the patient's ability to participate in the study. Patients with dyslipidaemia (diet controlled or treated with a statin) and/or metabolic syndrome (diet controlled or treated with metformin) may be entered into the study
- Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
- Patients with a pre-treatment SBP (if known) of >180 mmHg or a history of accelerated or malignant hypertension based on grade III (hypertensive haemorrhages and/or cotton wool spots) or grade IV (hypertensive papilloedema) retinopathy at any time
- History or presence of gastrointestinal (including irritable bowel disease), hepatic, or renal disease (creatinine clearance of ≤50 mL/minute calculated using the Cockcroft Gault equation) or any other condition known to interfere with the ADME of the investigational product.
- Patients with a history of surgery on the gastrointestinal tract (not including appendectomy or cholecystectomy) should also be excluded
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 |
|---|---|---|
| TC-5214Tablet oral bid days 1 to 7 | Drug | 1, 3 |
| TC-5214Tablet oral bid days 8 to 14 | Drug | 2, 4 |
Primary outcome
Part 1: To measure the effect of TC-5214 on sitting blood pressure in patients with chronic hypertension.
Time frame: Day 1 through to follow up
The following assessments will be measured and reported: - A change from baseline in blood pressure and pulse rate.
Part 2: To measure the effect of TC-5214 combined with treatment with the common classes of anti-hypertensive medication (calcium channel blockers, beta blockers, angiotensin converting enzyme inhibitors) on sitting blood pressure.
Time frame: Day 1 through to follow up
The following assessments will be measured and reported: A change from baseline in blood pressure and pulse rate.
2 secondary outcomes
To examine the safety and tolerability of TC-5214.
Time frame: Day 1 through to Follow up
The concentration of TC-5214 in plasma will be measured.
Time frame: Day 1 to day 28
Results and safety
The study was stopped early (reason given: Sponsor's decision to terminate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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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.
Hans A Eriksson, MD, PhD, MBA study director
AstraZeneca PharmaceuticalsKvarnbergagatan 12, 15185, Sodertalje, Sweden
James Ritter, MD,FRCP FFPM principal investigator
Quintiles Drug Research Unit at Guy's HospitalQuintiles Limited6 Newcomen StreetLondon SE1 1YR
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TC-5214 in people with Chronic Hypertension, run by AstraZeneca at 4 sites in 3 countries.
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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Sponsor's decision to terminate). Results are not available in the source record.
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?
Part 1: To measure the effect of TC-5214 on sitting blood pressure in patients with chronic hypertension. (time frame: Day 1 through to follow up). The study lists 2 primary outcomes in all. 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 Oct 2012.