Essential HypertensionPhase 1CKD-345NCT01842256
Study to Investigate the Effect of Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin.
A Phase 1 study testing Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg and atorvastatin 40mg in people with Essential Hypertension and Hyperlipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effect of telmisartan/s-amlodipine on the pharmacokinetic properties of atorvastatin. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension, Hyperlipidemia
- What is being tested?
- Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg and atorvastatin 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Jul 2013
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 20 aged and 45 aged in healthy male and female
- Body weight more than 55kg in male, 50kg in female
- Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2)
- If female, must include more than one among the items
- The menopause (there is no natural menses for at least 2 years)
- Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)
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- The male partner infertility before screening (Demonstrated azoospermia after vasectomy)and if this man is the only partner of the female subject.
- you are using one of the following contraceptive measure for 3 months before screening, and Necessarily you agree that used continuously contraceptive measure during the clinical trial and for 1 month after the final dosing investigational product.(But, should not use a device of contraception or oral contraceptive drug that containing a hormonal caused telmisartan, s-amlodipine, atorvastatin calcium drug interactions during the clinical trials)
- Abstinence.
- Physical interrupt method (such as a condom, contraceptive diaphoretic or cervical cap)
- In case of women of childbearing age, the serum β-hCG pregnancy test is negative, and urine β-hCG test is negative before taking the investigational product.
- If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms during clinical trials and do not sperm donation during clinical trials and until one month after the final dosage of investigational products
- Those who fully understand about this clinical trial after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent.
Who cannot join
- Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system,hemato-oncology disease, cardiovascular system (heart failure, etc.).or mental illness, or a history of mental disease.
- Have a gastrointestinal disease history that can affect drug absorption (Crohn, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery)
- Hypersensitivity reaction to drug or clinically significant hypersensitivity reaction in the history of Investigational drugs (telmisartan, s-amlodipine or atorvastatin calcium) or additives
- An impossible one who participates in clinical trial including screening tests(medical history taking, BP, physical examination, 12-lead ECG, blood \& urine laboratory test result) within 28 days before the beginning of study treatment.
- Defined by the following laboratory parameters:
- AST, ALT> 1.25*upper limit of normal range
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- Total bilirubin > 1.5* upper limit of normal range
- CPK > 1.5* upper limit of normal range
- eGFR(using by MDRD method) < 60 mL/min/1.73m2
- Sitting SBP > 150 mmHg or < 90 mmHg, Sitting DBP> 100 mmHg or < 50 mmHg , after 5minuts break.
- Drug abuse or have a history of drug abuse showed a positive for the Triage TOX drug on urine.
- Pregnant or lactating women.
- A heavy caffeine consumer(caffeine>5cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10cigarettes /day)
- Subject takes ethical drug or herbal medicine within 14days, OTC within 7days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of the subjects.
- Subject who takes inhibitors and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.
- Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
- Subject who treated with any investigational drugs within 60days before the beginning of study treatment (However, biologicals applies for 90 days, but can be based on a more extended period of time by considering the half-life.
- Previously donate whole blood within 60 days or component blood within 30days.
- An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
- Positive for Hepatitis B, Hepatitis C, HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Effect of Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin After Oral Administration in Healthy Volunteers
The purpose of this study is to investigate the effect of telmisartan/s-amlodipine on the pharmacokinetic properties of atorvastatin.
Read the detailed description
healthy subjects are administrated single-dose over the period Ⅰand Ⅱ(Crossover) of telmisartan/s-amlodipine, atorvastatin and atorvastatin.
- Conditions
- Essential Hypertension, Hyperlipidemia
- Being tested
- Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg, atorvastatin 40mg
- Keywords
- Telminouveau, Atorvastatin, Pharmacokinetic, Healthy volunteers
- Medical subject headings
- Essential Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mgDrug
- 3 Tablets (telmisartan 80mg, amlodipine 5mg, atorvastatin 40mg each one),
- oral intake, once in a period
- over the period Ⅰ\&Ⅱ(crossover)
atorvastatin 40mgDrug
- 1 Tablet (atorvastatin 40mg),
- oral intake, once in a period
- over the period Ⅰ\&Ⅱ(crossover)
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg | Experimental | Not described Receives: Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg; Drug: atorvastatin 40mg |
| Atorvastatin 40mg | Active comparator | Not described Receives: Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg; Drug: atorvastatin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
In the steady state atorvastatin 40mg AUClast
AUClast: Area under the plasma concentration time curve from zero time until the last measurable concentration.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state atorvastatin 40mg Cmax
Cmax: maximum plasma drug concentration
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
Secondary outcomes (9)
In the steady state atorvastatin 40mg AUCinf
AUCinf: Area Under the Concentration time curve from time zero to infinity
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state atorvastatin 40mg Tmax
Tmax: Time to Cmax
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state atorvastatin 40mg t1/2
t1/2: Observed terminal elimination half-life
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
Number of participants with adverse events
- Evaluated safety parameters included: physical examination, vital sign, laboratory test, ECG
- Adverse event monitoring
Measured: From 1day to 17days
In the steady state Orthohydroxy-atorvastatin AUClast
AUClast: Area under the plasma concentration time curve from zero time until the last measurable concentration.
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin Cmax
Cmax: maximum plasma drug concentration
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin AUCinf
AUCinf: Area Under the Concentration time curve from time zero to infinity
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin Tmax
Tmax: Time to Cmax
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin t1/2
t1/2: Observed terminal elimination half-life
Measured: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Soo Park, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842256
- Sponsor's protocol ID
- 142HPS13002
- Acronym
- CKD-345
- Status last verified
- Jul 2013
- First submitted
- 25 Apr 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Two-treatment, Two-period, Two-sequence Crossover Study to Investigate the Effect of Telmisartan/S-amlodipine on the Pharmacokinetic Properties of Atorvastatin After Oral Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01842256
- Acronym / sponsor ID
- CKD-345 / 142HPS13002
- Conditions
- Essential Hypertension, Hyperlipidemia
- Keywords
- Telminouveau, Atorvastatin, Pharmacokinetic, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Apr 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 purpose of this study is to investigate the effect of telmisartan/s-amlodipine on the pharmacokinetic properties of atorvastatin.
Detailed description
healthy subjects are administrated single-dose over the period Ⅰand Ⅱ(Crossover) of telmisartan/s-amlodipine, atorvastatin and atorvastatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg | Experimental | Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg, Drug: atorvastatin 40mg |
| Atorvastatin 40mg | Active comparator | Drug: Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg, Drug: atorvastatin 40mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Between 20 aged and 45 aged in healthy male and female
- Body weight more than 55kg in male, 50kg in female
- Body Mass Index more than 18.5 and under 25 (Body Mass Index(kg/m2)= kg/(m)2)
- If female, must include more than one among the items
- If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms during clinical trials and do not sperm donation during clinical trials and until one month after the final dosage of investigational products
Key exclusion criteria (20 listed)
- Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system,hemato-oncology disease, cardiovascular system (heart failure, etc.).or mental illness, or a history of mental disease.
- Have a gastrointestinal disease history that can affect drug absorption (Crohn, ulcers, etc.) or surgery (except simple appendectomy or hernia surgery)
- Hypersensitivity reaction to drug or clinically significant hypersensitivity reaction in the history of Investigational drugs (telmisartan, s-amlodipine or atorvastatin calcium) or additives
- An impossible one who participates in clinical trial including screening tests(medical history taking, BP, physical examination, 12-lead ECG, blood \& urine laboratory test result) within 28 days before the beginning of study treatment.
- Defined by the following laboratory parameters:
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 |
|---|---|---|
| Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg* 3 Tablets (telmisartan 80mg, amlodipine 5mg, atorvastatin 40mg each one), * oral intake, once in a period * over the period Ⅰ\&Ⅱ(crossover) | Drug | Atorvastatin 40mg, Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg |
| atorvastatin 40mg* 1 Tablet (atorvastatin 40mg), * oral intake, once in a period * over the period Ⅰ\&Ⅱ(crossover) | Drug | Atorvastatin 40mg, Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg |
Primary outcome
In the steady state atorvastatin 40mg AUClast
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
AUClast: Area under the plasma concentration time curve from zero time until the last measurable concentration.
In the steady state atorvastatin 40mg Cmax
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
Cmax: maximum plasma drug concentration
9 secondary outcomes
In the steady state atorvastatin 40mg AUCinf
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state atorvastatin 40mg Tmax
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state atorvastatin 40mg t1/2
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
Number of participants with adverse events
Time frame: From 1day to 17days
In the steady state Orthohydroxy-atorvastatin AUClast
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin Cmax
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin AUCinf
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin Tmax
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
In the steady state Orthohydroxy-atorvastatin t1/2
Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose
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 1 Aug 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.
Min Soo Park, Ph.D principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg and atorvastatin 40mg in people with Essential Hypertension and Hyperlipidemia, 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 13 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 1 Aug 2013. 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 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 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?
In the steady state atorvastatin 40mg AUClast (time frame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48hr post-dose). 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 1 Aug 2013.