Essential HypertensionPhase 2REDUCE-1NCT01264692
Essential Hypertension
A Phase 2 study testing ACT-280778 and Amlodipine in people with Essential Hypertension, run by Idorsia Pharmaceuticals Ltd. at 18 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral administration of ACT 280778 on DBP compared to placebo after 28 days. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- ACT-280778 and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 to 75 years (inclusive) at screening.
- Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
- 12-lead ECG without clinically relevant abnormalities measured at screening.
- Clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
- Signed informed consent in the local language prior to any study-mandated procedure
Who cannot join
- Mean SBP > 180 mmHg.
- Severe, malignant, or secondary hypertension.
- Episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
- E6 Severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
- Angina pectoris within 6 months prior to enrollment
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Israel11 sites
Clinical Investigative Site 4000
Afula, 18101
Clinical Investigative Site 1003
Ashkelon, 78278
Clinical Investigative Site 1008
Beersheba, 84101
Clinical Investigative Site 1004
Giv‘atayim, 53583
Clinical Investigative Site 1009
Holon, 58100
Clinical Investigative Site 1000
Jerusalem, 91004
Clinical Investigative Site 1006
Nazareth, 16100
Clinical Investigative Site 1007
Nazareth, 16100
Clinical Investigative Site 1005
Safed, 13100
Clinical Investigative Site 1010
Tel Aviv, 66872
Clinical Investigative Site 1012
Tel HaShomer, 52621
Serbia7 sites
Clinical Investigative Site 3001
Belgrade, 11000
Clinical InvestigativeSite 3003
Belgrade, 11000
Clinical Investigative Site 4001
Belgrade, 11040
Clinical Investigative Site 3004
Belgrade, 11080
Clinical Investigative Site 3000
Niška Banja, 18205
Clinical Investigative Site 4002
Pančevo, 26000
Clinical Investigative Site 3002
Zemun, 11080
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo- and Active-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of 10 mg of ACT-280778 in Patients With Mild to Moderate Essential Hypertension
The purpose of this study is to demonstrate the antihypertensive efficacy of once daily oral administration of ACT 280778 on DBP compared to placebo after 28 days.
- Conditions
- Essential Hypertension
- Being tested
- ACT-280778, Placebo, 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.
ACT-280778Drug
10 mg once daily for 28 ± 2 days
PlaceboDrug
Placebo oral capsules matching ACT-280778
AmlodipineDrug
10 mg once daily for 28 ± 2 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | ACT-280778 Receives: Drug: ACT-280778 |
| Treatment B | Placebo comparator | Placebo Receives: Drug: Placebo |
| Treatment C | Other | Amlodipine Receives: Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean(c) trough(d) SiDBP
Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP.
Measured: Baseline to day 28
Secondary outcomes (1)
Change in mean trough SiSBP.
Change from baseline to Day 28 (± 2 days) of Period 2 (Visit 7) in mean trough SiSBP.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionFeb 2012
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kasra Shakeri-Nejad, MD, PhD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01264692
- Sponsor's protocol ID
- AC-067A201
- Acronym
- REDUCE-1
- Status last verified
- Sep 2018
- First submitted
- 20 Dec 2010
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo- and Active-controlled, Parallel-group, Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of 10 mg of ACT-280778 in Patients With Mild to Moderate Essential Hypertension
- ClinicalTrials.gov ID
- NCT01264692
- Acronym / sponsor ID
- REDUCE-1 / AC-067A201
- Conditions
- Essential Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Dec 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 demonstrate the antihypertensive efficacy of once daily oral administration of ACT 280778 on DBP compared to placebo after 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: ACT-280778ACT-280778 |
| Treatment B | Placebo comparator | Drug: PlaceboPlacebo |
| Treatment C | Other | Drug: AmlodipineAmlodipine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females aged 18 to 75 years (inclusive) at screening.
- Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight at least 50 kg at screening and prior to enrollment.
- 12-lead ECG without clinically relevant abnormalities measured at screening.
- Clinical chemistry, hematology, coagulation, virus serology, and urinalysis test results not deviating to a clinically relevant extent from the normal range at screening.
- Signed informed consent in the local language prior to any study-mandated procedure
Key exclusion criteria (6 listed)
- Mean SBP > 180 mmHg.
- Severe, malignant, or secondary hypertension.
- Episodes of hypertensive crisis or hypertensive emergency within 6 months prior to enrollment.
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions considered to be of clinical significance.
- E6 Severe coronary artery disease indicated by myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft within the last 12 months prior to enrollment.
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 |
|---|---|---|
| ACT-28077810 mg once daily for 28 ± 2 days | Drug | Treatment A |
| PlaceboPlacebo oral capsules matching ACT-280778 | Drug | Treatment B |
| Amlodipine10 mg once daily for 28 ± 2 days | Drug | Treatment C |
Primary outcome
Change in mean(c) trough(d) SiDBP
Time frame: Baseline to day 28
Change from baseline(b) to Day 28 (± 2 days) of Period 2 (Visit 7)in mean(c) trough(d) SiDBP.
1 secondary outcome
Change in mean trough SiSBP.
Time frame: Baseline to Day 28
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 27 Sep 2018.
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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.
Kasra Shakeri-Nejad, MD, PhD study director
Actelion
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACT-280778 and Amlodipine in people with Essential Hypertension, run by Idorsia Pharmaceuticals Ltd. at 18 sites in 2 countries.
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 5 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 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Israel, Serbia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 mean(c) trough(d) SiDBP (time frame: Baseline to day 28). 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 27 Sep 2018.