HypertensionPhase 3NCT02087540
Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
A Phase 3 study testing Telmisartan 80mg, Rosuvastatin 20mg and Rosuvastatin 10mg in people with Hypertension and Hyperlipidemia, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Hypertension, Hyperlipidemia
- What is being tested?
- Telmisartan 80mg, Rosuvastatin 20mg and Rosuvastatin 10mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Dec 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Men and women >18 years of age
- Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent
Who cannot join
- Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,.
- Other exclusions applied
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Saint Mary's Hosiptal
Seoul
wook-seong chung, MD, chungws@catholic.ac.kr
wook-seong Chung, MD
About this study
Official title: A Randomized, Double-blind, Multi-center, Factorial Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Telmisartan 80mg, Rosuvastatin 20mg, Rosuvastatin 10mg, Placebo(for Telmisartan 80mg), Placebo(for Rosuvastatin 20mg)
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan 80mgDrug
Rosuvastatin 20mgDrug
Rosuvastatin 10mgDrug
Placebo(for Telmisartan 80mg)Drug
Placebo(for Rosuvastatin 20mg)Drug
Placebo(for Rosuvastatin 10mg)Drug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan 80mg & Rosuvastatin 20mg | Experimental | PO, Once Daily, 8 weeks Receives: Drug: Telmisartan 80mg; Drug: Rosuvastatin 20mg; Drug: Placebo(for Rosuvastatin 10mg) |
| Telmisartan 80mg & Rosuvastatin 10mg | Experimental | PO, Once Daily, 8weeks Receives: Drug: Telmisartan 80mg; Drug: Rosuvastatin 10mg; Drug: Placebo(for Rosuvastatin 20mg) |
| Telmisartan placebo & Rosuvastatin 20mg | Active comparator | PO, Once Daily, 8 weeks Receives: Drug: Rosuvastatin 20mg; Drug: Placebo(for Telmisartan 80mg); Drug: Placebo(for Rosuvastatin 10mg) |
| Telmisartan Placebo & Rosuvastatin 10mg | Active comparator | PO, Once Daily, 8 weeks Receives: Drug: Rosuvastatin 10mg; Drug: Placebo(for Telmisartan 80mg); Drug: Placebo(for Rosuvastatin 20mg) |
| Telmisartan 80mg & Rosuvastatin placebo | Active comparator | PO, Once Daily, 8 weeks Receives: Drug: Telmisartan 80mg; Drug: Placebo(for Telmisartan 80mg); Drug: Placebo(for Rosuvastatin 20mg) |
| Telmisartan placebo & Rosuvastatin placebo | Placebo comparator | PO, Once Daily, 8 weeks Receives: Drug: Placebo(for Telmisartan 80mg); Drug: Placebo(for Rosuvastatin 20mg); Drug: Placebo(for Rosuvastatin 10mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
•Change in seated diastolicblood pressure at 8 weeks compared to the base value
Measured: at the 8 weeks
Change in LDL-Cat 8 weeks compared to the base value (% change)
Measured: at the 8 weeks
Secondary outcomes (6)
Change in seateddiastolic blood pressure
Measured: at 2,4 8 weeks
Change in seated systolic blood pressure
Measured: at 2,4,8weeks
Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)]
Measured: at 2, 4 and 8 weeks
Change in LDL-Cat compared to the base value (% change)
Measured: 2, 4 and 8 weeks
Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change)
Measured: at 2, 4 and 8 weeks
Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL)
Measured: at 2, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2014 (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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087540
- Sponsor's protocol ID
- ID_Telotan_1203
- Status last verified
- Mar 2014
- First submitted
- 5 Mar 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Factorial Phase III Clinical Trial to Evaluate the Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
- ClinicalTrials.gov ID
- NCT02087540
- Acronym / sponsor ID
- ID_Telotan_1203
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 14 Mar 2014 (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.
To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Telmisartan 80mg & Rosuvastatin 20mg | Experimental | Drug: Telmisartan 80mg, Drug: Rosuvastatin 20mg, Drug: Placebo(for Rosuvastatin 10mg)PO, Once Daily, 8 weeks |
| Telmisartan 80mg & Rosuvastatin 10mg | Experimental | Drug: Telmisartan 80mg, Drug: Rosuvastatin 10mg, Drug: Placebo(for Rosuvastatin 20mg)PO, Once Daily, 8weeks |
| Telmisartan placebo & Rosuvastatin 20mg | Active comparator | Drug: Rosuvastatin 20mg, Drug: Placebo(for Telmisartan 80mg), Drug: Placebo(for Rosuvastatin 10mg)PO, Once Daily, 8 weeks |
| Telmisartan Placebo & Rosuvastatin 10mg | Active comparator | Drug: Rosuvastatin 10mg, Drug: Placebo(for Telmisartan 80mg), Drug: Placebo(for Rosuvastatin 20mg)PO, Once Daily, 8 weeks |
| Telmisartan 80mg & Rosuvastatin placebo | Active comparator | Drug: Telmisartan 80mg, Drug: Placebo(for Telmisartan 80mg), Drug: Placebo(for Rosuvastatin 20mg)PO, Once Daily, 8 weeks |
| Telmisartan placebo & Rosuvastatin placebo | Placebo comparator | Drug: Placebo(for Telmisartan 80mg), Drug: Placebo(for Rosuvastatin 20mg), Drug: Placebo(for Rosuvastatin 10mg)PO, Once Daily, 8 weeks |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Men and women >18 years of age
- Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent
Key exclusion criteria (2 listed)
- Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,.
- Other exclusions applied
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 | Drug | Telmisartan 80mg & Rosuvastatin 10mg, Telmisartan 80mg & Rosuvastatin 20mg, Telmisartan 80mg & Rosuvastatin placebo |
| Rosuvastatin 20mg | Drug | Telmisartan 80mg & Rosuvastatin 20mg, Telmisartan placebo & Rosuvastatin 20mg |
| Rosuvastatin 10mg | Drug | Telmisartan 80mg & Rosuvastatin 10mg, Telmisartan Placebo & Rosuvastatin 10mg |
| Placebo(for Telmisartan 80mg) | Drug | Telmisartan 80mg & Rosuvastatin placebo, Telmisartan Placebo & Rosuvastatin 10mg, Telmisartan placebo & Rosuvastatin 20mg, Telmisartan placebo & Rosuvastatin placebo |
| Placebo(for Rosuvastatin 20mg) | Drug | Telmisartan 80mg & Rosuvastatin 10mg, Telmisartan 80mg & Rosuvastatin placebo, Telmisartan Placebo & Rosuvastatin 10mg, Telmisartan placebo & Rosuvastatin placebo |
| Placebo(for Rosuvastatin 10mg) | Drug | Telmisartan 80mg & Rosuvastatin 20mg, Telmisartan placebo & Rosuvastatin 20mg, Telmisartan placebo & Rosuvastatin placebo |
Primary outcome
•Change in seated diastolicblood pressure at 8 weeks compared to the base value
Time frame: at the 8 weeks
Change in LDL-Cat 8 weeks compared to the base value (% change)
Time frame: at the 8 weeks
6 secondary outcomes
Change in seateddiastolic blood pressure
Time frame: at 2,4 8 weeks
Change in seated systolic blood pressure
Time frame: at 2,4,8weeks
Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)]
Time frame: at 2, 4 and 8 weeks
Change in LDL-Cat compared to the base value (% change)
Time frame: 2, 4 and 8 weeks
Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change)
Time frame: at 2, 4 and 8 weeks
Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL)
Time frame: at 2, 4 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
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.
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 Telmisartan 80mg, Rosuvastatin 20mg and Rosuvastatin 10mg in people with Hypertension and Hyperlipidemia, run by IlDong Pharmaceutical Co Ltd 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 3 inclusion and 2 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 14 Mar 2014. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
•Change in seated diastolicblood pressure at 8 weeks compared to the base value (time frame: at the 8 weeks). 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 14 Mar 2014.