Primary HypertensionPhase 4MARSNCT00819104
A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components
A Phase 4 study testing Metoprolol XL 50mg + Amlodipine 5mg, Metoprolol XL 25 mg + Amlodipine 2.5mg and Metoprolol XL 50mg in people with Primary Hypertension, run by AstraZeneca at 11 sites in India.
Trial summary
This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- Metoprolol XL 50mg + Amlodipine 5mg, Metoprolol XL 25 mg + Amlodipine 2.5mg and Metoprolol XL 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 11 sitesIndia
- Study dates
- Nov 2008to Aug 2009
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of hypertension (primary) , as judged by 2 BP measurements before randomisation
- Those who have given their written consent for the study.
Who cannot join
- Patients of other forms of hypertension (other than primary)
- Those who have consistently BP > /=180/120mmHg
- Patients with a prior history of chest pain, heart attacks, conduction defects and strokes.
- Patients of diabetes requiring insulin,asthma and kidney diseases.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
India11 sites
Research Site
Ahmedabad, Gujarat
Research Site
Bangalore, Karnataka
Research Site
Bangalore
Research Site
Calicut, Kerala
Research Site
Delhi, National Capital Territory of Delhi
Research Site
Hyderabad, Andhra Pradesh
Research Site
Jaipur, Rajasthan
Research Site
Kolkata, West Bengal
Research Site
Lucknow, Uttar Pradesh
Research Site
Mumbai, Maharashtra
Research Site
Pune, Maharashtra
About this study
Official title: A Five-arm, Randomised, Open Label, Multi-centre, Prospective Study to Compare the Efficacy, Safety and Tolerability of Metoprolol XL Plus Amlodipine Combination (Selomax TM) With Metoprolol XL and Amlodipine as Individual Components in Management of Hypertension in Indian Patients.
This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease.
- Conditions
- Primary Hypertension
- Being tested
- Metoprolol XL 50mg + Amlodipine 5mg, Metoprolol XL 25 mg + Amlodipine 2.5mg, Metoprolol XL 50mg, Metoprolol XL 25 mg, Amlodipine 5mg
- Keywords
- Primary hypertension, Metoprolol XL, Amlodipine
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol XL 50mg + Amlodipine 5mgDrug
Also called Selomax 50/5
tablet,oral,OD,8 weeks
Metoprolol XL 25 mg + Amlodipine 2.5mgDrug
Also called Selomax 25/2.5
tablet,oral,OD,8 weeks
Metoprolol XL 50mgDrug
Also called Revelol XL
tablet,oral,OD,8 weeks
Metoprolol XL 25 mgDrug
Also called Revelol XL
tablet,oral,OD,8 weeks
Amlodipine 5mgDrug
Also called Amlogard
tablet,oral,OD,8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FDC of Metoprolol XL 50mg + Amlodipine 5mg Receives: Drug: Metoprolol XL 50mg + Amlodipine 5mg |
| 2 | Experimental | FDC of Metoprolol XL 25mg + Amlodipine 2.5mg Receives: Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg |
| 3 | Active comparator | Extended release Metoprolol succinate Receives: Drug: Metoprolol XL 50mg |
| 4 | Active comparator | Extended release Metoprolol succinate Receives: Drug: Metoprolol XL 25 mg |
| 5 | Active comparator | Amlodipine 5mg in immediate release formulation Receives: Drug: Amlodipine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
Measured: 8 weeks
Secondary outcomes (3)
Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.
Measured: 8 weeks
Change in the heart rate,Number of responders & control rates.
Measured: 8 weeks
Incidence of adverse events (serious and non-serious) in each arm.Change in hemogram, serum chemistry (Liver function tests (LFT), Renal function tests (RFT), plasma lipids, Blood Glucose, HbA1c), and Ur.albumin
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startNov 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. John's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819104
- Sponsor's protocol ID
- D4022L00006
- Acronym
- MARS
- Status last verified
- Sep 2009
- First submitted
- 7 Jan 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Five-arm, Randomised, Open Label, Multi-centre, Prospective Study to Compare the Efficacy, Safety and Tolerability of Metoprolol XL Plus Amlodipine Combination (Selomax TM) With Metoprolol XL and Amlodipine as Individual Components in Management of Hypertension in Indian Patients.
- ClinicalTrials.gov ID
- NCT00819104
- Acronym / sponsor ID
- MARS / D4022L00006
- Conditions
- Primary Hypertension
- Keywords
- Primary hypertension, Metoprolol XL, Amlodipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- St. John's Research Institute
- Study start
- Nov 2008
- Study completion
- Aug 2009 (actual)
- First posted
- 8 Jan 2009 (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 randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Metoprolol XL 50mg + Amlodipine 5mgFDC of Metoprolol XL 50mg + Amlodipine 5mg |
| 2 | Experimental | Drug: Metoprolol XL 25 mg + Amlodipine 2.5mgFDC of Metoprolol XL 25mg + Amlodipine 2.5mg |
| 3 | Active comparator | Drug: Metoprolol XL 50mgExtended release Metoprolol succinate |
| 4 | Active comparator | Drug: Metoprolol XL 25 mgExtended release Metoprolol succinate |
| 5 | Active comparator | Drug: Amlodipine 5mgAmlodipine 5mg in immediate release formulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of hypertension (primary) , as judged by 2 BP measurements before randomisation
- Those who have given their written consent for the study.
Key exclusion criteria (4 listed)
- Patients of other forms of hypertension (other than primary)
- Those who have consistently BP > /=180/120mmHg
- Patients with a prior history of chest pain, heart attacks, conduction defects and strokes.
- Patients of diabetes requiring insulin,asthma and kidney diseases.
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 |
|---|---|---|
| Metoprolol XL 50mg + Amlodipine 5mgAlso: Selomax 50/5tablet,oral,OD,8 weeks | Drug | 1 |
| Metoprolol XL 25 mg + Amlodipine 2.5mgAlso: Selomax 25/2.5tablet,oral,OD,8 weeks | Drug | 2 |
| Metoprolol XL 50mgAlso: Revelol XLtablet,oral,OD,8 weeks | Drug | 3 |
| Metoprolol XL 25 mgAlso: Revelol XLtablet,oral,OD,8 weeks | Drug | 4 |
| Amlodipine 5mgAlso: Amlogardtablet,oral,OD,8 weeks | Drug | 5 |
Primary outcome
Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
Time frame: 8 weeks
3 secondary outcomes
Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.
Time frame: 8 weeks
Change in the heart rate,Number of responders & control rates.
Time frame: 8 weeks
Incidence of adverse events (serious and non-serious) in each arm.Change in hemogram, serum chemistry (Liver function tests (LFT), Renal function tests (RFT), plasma lipids, Blood Glucose, HbA1c), and Ur.albumin
Time frame: 8 weeks
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 9 Sep 2009.
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol XL 50mg + Amlodipine 5mg, Metoprolol XL 25 mg + Amlodipine 2.5mg and Metoprolol XL 50mg in people with Primary Hypertension, run by AstraZeneca at 11 sites in India.
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 2 inclusion and 4 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 9 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 in BP with Selomax™ 50/5 at the end of the randomisation treatment period. (time frame: 8 weeks). 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 9 Sep 2009.