HypertensionPhase 4NCT01277822

Efficacy of Losartan + Amlodipine Compared to Amlodipine Alone in the Treatment of Uncontrolled High Blood Pressure (MK-0954F-399)

A Phase 4 study testing Losartan (+) amlodipine and Amlodipine camsylate in people with Hypertension, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertension
What is being tested?: Losartan (+) amlodipine and Amlodipine camsylate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 334 participants
Where: No sites listed yet
Study dates: 30 May 2011to 22 Apr 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participants with essential hypertension:
who are on single drug therapy
who are newly diagnosed and not yet taking any drug therapy, or have not had any drug therapy for at least 2 weeks prior to entering study
who have blood pressure readings of 90mmHg ≤ MSDBP < 110mmHg and 140mmHg ≤ MSSBP <180mmHg after 2 weeks wash-out for patients on single agent.
Randomization (Visit 3)
After dosing of amlodipine 5mg for 6 weeks, blood pressure readings are:
90mmHg ≤ MSDBP < 110mmHg and 140mmHg ≤ MSSBP < 180mmHg.

Who cannot join

Participant with MSDBP ≥ 110mmHg or MSSBP ≥ 180mmHg.
Participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients).
Participant with known secondary hypertension of any etiology.
Participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure.
Participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin II receptor blockers.
Participant showing positive in pregnancy test, lactating woman, or woman who intends to get pregnant during the study period.

About this study

Official title: The 8 Weeks, Multicenter, Randomized, Double-blind, Clinical Study To Evaluate Efficacy Of Treatment With Losartan/Amlodipine 100/5 mg Combination Compared To Amlodipine 10 mg Monotherapy In Hypertensive Patients Who Are Not Appropriately Respond To Amlodipine 5 mg Monotherapy

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.

Conditions: Hypertension
Being tested: Losartan (+) amlodipine, Placebo to match losartan/amlodipine tablets, Amlodipine camsylate, Placebo to match amlodipine
Keywords: Hypertension, Uncontrolled hypertension, High blood pressure, Uncontrolled high blood pressure, Untreated high blood pressure, Untreated hypertension, Essential hypertension
Medical subject headings: Hypertension, Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Losartan (+) amlodipineDrug
Also called COZAAR XQ™
One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.
Placebo to match losartan/amlodipine tabletsDrug
One tablet containing placebo, orally, once daily, for 8 weeks.
Amlodipine camsylateDrug
2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.
Placebo to match amlodipineDrug
2 tablets containing placebo, orally, once daily, for 8 weeks.

Study groups in NCT01277822
Study group	Role	What they receive
Losartan/amlodipine Treatment Arm	Experimental	One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks. Receives: Drug: Losartan (+) amlodipine; Drug: Placebo to match amlodipine
Amlodipine Treatment Arm	Active comparator	2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks. Receives: Drug: Placebo to match losartan/amlodipine tablets; Drug: Amlodipine camsylate

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Measured: Baseline and Week 8

Secondary outcomes (7)

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4
Diastolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Measured: Baseline and Week 4
Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
Systolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Measured: Baseline and Week 8
Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4
Systolic blood pressure was assessed at baseline and after 4 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.
Measured: Baseline and Week 4
Percentage of Participants Who Achieve Target Blood Pressure at Week 8
Participants were evaluated at Week 8 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.
Measured: Week 8
Percentage of Participants Who Achieve Target Blood Pressure at Week 4
Participants were evaluated at Week 4 to ascertain if target blood pressure had been obtained. Criteria for meeting target BP were: sitting diastolic BP (sitDBP) <90mmHg or sitting systolic BP (sitSBP) <140mmHg) or sitDBP change more than 10mmHg from baseline or sitSBP change more than 20mmHg from baseline.
Measured: Week 4
Percentage of Participants Who Had Peripheral Edema During the Study
A pitting assessment of edema on both legs was performed at baseline and throughout the study. Participants were assessed in a seated position with both feet extended and the right ankle in a neutral dorsiflexion position. The index finger was pressed firmly over the bony prominence approximately 3cm proximal to the midpoint of the medial malleolus of the right ankle and will be held for three seconds. Presence of a residual indentation in the area after releasing pressure on the index finger was considered positive for pitting edema.
Measured: up to 8 weeks
Change From Baseline in Ankle Circumference at Week 8
Each ankle was marked with a semi-permanent marker at approximately 3 cm proximal to the midpoint of the medial malleolus to aid consistency in the performance of the measurements. Ankle circumference was measured in both ankles at baseline and Week 8 using a tension controlled tape to minimize error.
Measured: Baseline and Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 201122 Apr 2013

First posted17 Jan 2011 (estimated)
Study start30 May 2011
Primary completion22 Apr 2013
Study completion22 Apr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01277822
Sponsor's protocol ID: 0954F-399
Status last verified: Feb 2022
First submitted: 13 Jan 2011
Last updated: 20 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The 8 Weeks, Multicenter, Randomized, Double-blind, Clinical Study To Evaluate Efficacy Of Treatment With Losartan/Amlodipine 100/5 mg Combination Compared To Amlodipine 10 mg Monotherapy In Hypertensive Patients Who Are Not Appropriately Respond To Amlodipine 5 mg Monotherapy
ClinicalTrials.gov ID: NCT01277822
Acronym / sponsor ID: 0954F-399
Conditions: Hypertension
Keywords: Hypertension, Uncontrolled hypertension, High blood pressure, Uncontrolled high blood pressure, Untreated high blood pressure, Untreated hypertension, Essential hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 30 May 2011 (actual)
Primary completion: 22 Apr 2013 (actual)
Study completion: 22 Apr 2013 (actual)
First posted: 17 Jan 2011 (estimated)
Results: Posted 24 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Losartan/amlodipine Treatment Arm	Experimental	Drug: Losartan (+) amlodipine, Drug: Placebo to match amlodipineOne combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
Amlodipine Treatment Arm	Active comparator	Drug: Placebo to match losartan/amlodipine tablets, Drug: Amlodipine camsylate2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participants with essential hypertension:
Randomization (Visit 3)

Key exclusion criteria (6 listed)

Participant with MSDBP ≥ 110mmHg or MSSBP ≥ 180mmHg.
Participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients).
Participant with known secondary hypertension of any etiology.
Participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure.
Participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin II receptor blockers.

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
Losartan (+) amlodipineAlso: COZAAR XQ™One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.	Drug	Losartan/amlodipine Treatment Arm
Placebo to match losartan/amlodipine tabletsOne tablet containing placebo, orally, once daily, for 8 weeks.	Drug	Amlodipine Treatment Arm
Amlodipine camsylate2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.	Drug	Amlodipine Treatment Arm
Placebo to match amlodipine2 tablets containing placebo, orally, once daily, for 8 weeks.	Drug	Losartan/amlodipine Treatment Arm

Primary outcome

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8
Time frame: Baseline and Week 8
Diastolic blood pressure was assessed at baseline and after 8 weeks of treatment with the participant in a seated position using an auto sphygmomanometer. Three measurements were performed at 2-minute intervals and the average of the 3 values of was recorded.

7 secondary outcomes

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 4
Time frame: Baseline and Week 4
Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
Time frame: Baseline and Week 8
Change in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4
Time frame: Baseline and Week 4
Percentage of Participants Who Achieve Target Blood Pressure at Week 8
Time frame: Week 8
Percentage of Participants Who Achieve Target Blood Pressure at Week 4
Time frame: Week 4
Percentage of Participants Who Had Peripheral Edema During the Study
Time frame: up to 8 weeks
Change From Baseline in Ankle Circumference at Week 8
Time frame: Baseline and Week 8

Results and safety

Results posted to the registry on 24 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Losartan/Amlodipine	168	153
Amlodipine	166	155

Primary outcome: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8

Time frame: Baseline and Week 8. Mean (Standard Deviation). Unit: mmHg

Measure	Losartan/Amlodipine n = 162	Amlodipine n = 160
Value	-10.1 (7.6)	-8.8 (7.8)

Losartan/Amlodipine vs Amlodipine: Mean Difference (Final Values): -1.3 (95% CI -3.0 to 0.4), p = 0.1339, t-test, 2 sided

Population analysed: Full Analysis Set defined as all participants who were randomized, took at least 1 dose of study drug, and had blood pressure measurements at baseline and at least 1 post-randomization blood pressure measurement.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Losartan 100mg/Amlodipine 5mg	6 of 168 (3.6%)	6 of 168 (3.6%)	Not reported
Amlodipine 10mg	5 of 166 (3%)	11 of 166 (6.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Losartan (+) amlodipine and Amlodipine camsylate in people with Hypertension, run by Organon and Co.

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 7 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: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 24 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 (time frame: Baseline and Week 8). 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 NCT01277822.

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 20 Jun 2024.