HypertensionPhase 3NCT01127217
Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension
A Phase 3 study testing amlodipine/losartan and amlodipine in people with Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- amlodipine/losartan and amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Mar 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 aged or over
- Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
- Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg
Who cannot join
- Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
- ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
- History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
- Secondary hypertension or suspected to be
- Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months
- Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus
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- History of severe neurovascular disease, severe heart disease
- Known as moderate or malignant retinopathy.
- Renal diseases; serum creatinine ≥ 2mg/dl
- Hepatic diseases; increase in ALT or AST ≥ 2xUNL
- Anuria
- Hyponatremia/hypokalemia or hypercalcemia
- Active Gout
- Surgical or medical diseases which might significantly change ADME of medicines
- History of malignant tumor
- Autoimmune diseases
- History of alcohol or drug abuse
- Positive to pregnancy test, nursing mother, woman with an intention of pregnancy
- Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension
The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.
- Conditions
- Hypertension
- Being tested
- amlodipine/losartan, amlodipine
- Keywords
- amlodipine, losartan, hypertension, stage 2
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlodipine/losartanDrug
Also called amosartan
amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)
amlodipineDrug
Also called amodipin(amlodipine camsylate)
amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)
| Study group | Role | What they receive |
|---|---|---|
| amlodipine/losartan | Experimental | Not described Receives: Drug: amlodipine/losartan |
| amlodipine | Active comparator | Not described Receives: Drug: amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in MSSBP
Measured: Baseline, Week 6
Secondary outcomes (3)
Change from baseline in MSSBP
Measured: Baseline, Week 2 and 8
Change from baseline MSDBP
Measured: Baseline, Week 2, 6, and 8
Blood pressure responder rate
Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg or MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline.
Measured: Baseline, Week 2, 6, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127217
- Sponsor's protocol ID
- HM-ALOS-303
- Status last verified
- Sep 2010
- First submitted
- 19 May 2010
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.
PubMed 22035131
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension
- ClinicalTrials.gov ID
- NCT01127217
- Acronym / sponsor ID
- HM-ALOS-303
- Conditions
- Hypertension
- Keywords
- amlodipine, losartan, hypertension, stage 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 20 May 2010 (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 evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amlodipine/losartan | Experimental | Drug: amlodipine/losartan |
| amlodipine | Active comparator | Drug: amlodipine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 aged or over
- Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
- Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg
Key exclusion criteria (20 listed)
- Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
- ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
- History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
- Secondary hypertension or suspected to be
- Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 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 |
|---|---|---|
| amlodipine/losartanAlso: amosartanamlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg) | Drug | amlodipine/losartan |
| amlodipineAlso: amodipin(amlodipine camsylate)amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg) | Drug | amlodipine |
Primary outcome
Change from baseline in MSSBP
Time frame: Baseline, Week 6
3 secondary outcomes
Change from baseline in MSSBP
Time frame: Baseline, Week 2 and 8
Change from baseline MSDBP
Time frame: Baseline, Week 2, 6, and 8
Blood pressure responder rate
Time frame: Baseline, Week 2, 6, 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 14 Sep 2010.
- Derived from this study: PubMed 22035131Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.
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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.
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 amlodipine/losartan and amlodipine in people with Hypertension, run by Hanmi Pharmaceutical Company Limited 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 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 14 Sep 2010. 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?
Change from baseline in MSSBP (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01127217, which also lists 1 linked publication.
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 Sep 2010.