Selexipag for Hypertension

1
Effectiveness
2
Safety
Royal Free Hospital, London, United Kingdom
Hypertension+3 More
Selexipag - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hypertension

Study Summary

This study is evaluating whether a drug which is already approved for one type of pulmonary hypertension may be helpful for another type of pulmonary hypertension.

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Eligible Conditions

  • Hypertension
  • Sarcoidosis
  • Hypertension, Pulmonary
  • Sarcoidosis-associated Pulmonary Hypertension

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Selexipag will improve 1 primary outcome in patients with Hypertension. Measurement will happen over the course of Up to week 26, within 2-5 hours post-dose.

Week 26
Pulmonary Vascular Resistance (PVR) on Study Intervention up to Week 26

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Selexipag
Headache
77%
Diarrhoea
53%
Nausea
42%
Pain in Jaw
38%
Vomiting
25%
Pain in Extremity
21%
Arthralgia
21%
Dizziness
13%
Myalgia
11%
Dyspepsia
11%
Upper Respiratory Tract Infection
11%
Nasopharyngitis
9%
Fatigue
9%
Flushing
9%
Nasal Congestion
9%
Back Pain
8%
Decreased Appetite
8%
Dyspnoea
8%
Cough
6%
Oedema Peripheral
6%
Epistaxis
6%
Oropharyngeal Pain
4%
Abdominal Pain Upper
4%
Palpitations
4%
Non-Cardiac Chest Pain
4%
Rash
4%
Lower Respiratory Tract Infection
4%
Migraine
2%
Right Ventricular Failure
2%
Respiratory Tract Infection
2%
Abdominal Distension
2%
Atrial Flutter
2%
Vision Blurred
0%
Hot Flush
0%
Multiple Sclerosis Relapse
0%
Glossitis
0%
Tonsillitis
0%
Urinary Tract Infection
0%
Thyroid Nodule Removal
0%
Pneumonia
0%
Syncope
0%
Pleural Effusion
0%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03078907) in the Selexipag ARM group. Side effects include: Headache with 77%, Diarrhoea with 53%, Nausea with 42%, Pain in Jaw with 38%, Vomiting with 25%.

Trial Design

2 Treatment Groups

Placebo
Selexipag 200 micro gram (μg)
Placebo group

This trial requires 74 total participants across 2 different treatment groups

This trial involves 2 different treatments. Selexipag is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Selexipag 200 micro gram (μg)
Drug
Study intervention will be up-titrated to allow each participant to reach their individual maximum tolerated dose (iMTD), in the range of 200 μg to1600 μg (ie, 1 to 8 tablets) twice daily/once daily. Dosing frequency will be twice daily, except for participants with moderate hepatic impairment (Child-Pugh Class B) or who are concomitantly taking (a) moderate CYP2C8 inhibitor(s), who receive study intervention once daily. The dose will be up-titrated by the investigator/delegate in 200 μg twice daily/once daily increments at weekly intervals during scheduled TCs until reaching the iMTD. If the dose regimen is not well tolerated or symptoms cannot be fully managed with symptomatic treatment, the duration of the titration step can be prolonged to 2 weeks. If needed, the dose can be reduced by 200 μg twice daily/once daily.
Placebo
Drug
The comparator will be administered similarly to the experimental intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selexipag
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 26, within 2-5 hours post-dose
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to week 26, within 2-5 hours post-dose for reporting.

Closest Location

University of Florida - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have a confirmed diagnosis of sarcoidosis as per ATS criteria. show original
Sarcoidosis-associated precapillary PH, confirmed by RHC (at rest) within 90 days prior to randomization.
PH severity according to modified WHO FC II-IV at Screening and randomization; participants in WHO FC IV must be in a stable condition and able to perform a 6MWT.
Either not receiving treatment with PH-specific treatment or oral PH-specific monotherapy (ie, riociguat or PDE5i or ERA); if on oral PH-specific monotherapy then treatment had to be stable (ie, no introduction of new therapies or changes in dose) for at least 90 days prior to both and the RHC qualifying for enrollment and randomization
Stable sarcoidosis treatment regimen, ie, no new specific anti-inflammatory treatment for sarcoidosis for at least 90 days, and stable dose(s) for at least 30 days prior to both the RHC qualifying for enrollment and randomization
A 6-minute walk test (6MWT) is performed at the same time as the screening test. show original
Forced Vital Capacity (FVC) greater than (>) 50 percent (%) and Forced Expiratory Volume (in 1 second) (FEV1) > 50% of predicted at Screening
You have a low diffusing capacity for carbon monoxide (DLCO) and a high residual volume show original
You are of childbearing potential and agree to undertake monthly urine pregnancy tests and to practice an acceptable method of contraception and agreeing to remain on an acceptable method while receiving study intervention and until 30 days after last dose of study intervention. show original
You are a woman who has been using hormonal contraceptives for at least 30 days prior to randomization. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes hypertension?

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Hypertension is associated with a number of environmental exposures such as physical activity, alcohol use, smoking, diet, body weight and a number of psychosocial factors such as stress. It seems that both genetic and physiological factors are at least partially responsible for establishing hypertension.

Unverified Answer

How many people get hypertension a year in the United States?

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The prevalence of hypertension is quite high in this cohort of US adults. The prevalence of hypertension among whites older than age 40 is 3.2 times higher than that among nonwhites.

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What are the signs of hypertension?

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Hypertension is usually an insidious disease that presents gradually. Hypertension, like any chronic diseases, causes a multitude of nonspecific signs and symptoms, some of which may present years before the diagnosis of hypertension is suspected. Most common complaints are: headache, visual problems, dizziness and fatigue. For this reason, a comprehensive assessment is essential.

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What is hypertension?

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The cardiovascular system is subject to the action of the renal system. Both the kidneys and the brain are involved in the regulation of blood pressure dynamics to maintain homeostatic pressure in healthy individuals.

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What are common treatments for hypertension?

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What options are available for treatment of hypertension? This review shows that some of the common treatments used for hypertension are effective, but a higher use of medications such as amlodipine and alpha-blockers might increase mortality.

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Can hypertension be cured?

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Hypertension may not be "cured." However, the results of recent studies suggest that blood pressure-lowering medications can be effective in the control of blood pressure.

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How does selexipag work?

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The dose-range examined in this study supports its potential usefulness for reducing PE, for which it may be indicated for patients suffering from severe PE, in whom PE-lowering drug therapy is contraindicated, and on which it may prove effective by decreasing the frequency of PE events and thereby enhancing health status of patients. Considering the well-characterized clinical safety profile of selexipag, this drug may represent an attractive, new option for treatment of severe PE, offering clinicians a new mechanism for reducing its frequency and severity. The observed reduction in PE events is in line with the clinical efficacy of non-selective, short-acting PPARgamma ligands as an add-on to statin treatment.

Unverified Answer

Has selexipag proven to be more effective than a placebo?

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Although selexipag was not found to be more effective on the primary outcome in the main SEARCH trial over placebo in people with heart failure, in a follow-up of individuals in both treatment arms this result was supported in a meta-analysis.

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What is selexipag?

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Selexipag is a selective and irreversible antagonist of the imidazoline receptor I at doses clinically achievable in humans. Selexipag has no cardiovascular effects when dosed in normal subjects or those with mild to moderate hypertension [HbA (1c) ≥ 7 %]. Oral selexipag has a short half-life (30 hr) with little food-related reduction in AUC values at the steady-state pharmacodynamic dose of selexipag 50 mg twice daily.

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What are the latest developments in selexipag for therapeutic use?

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Sipagliflozin and selexipag offer a broader range of therapeutic opportunities than first-generation SGLT2 receptor inhibitors and represent a new exciting class of therapeutically useful drugs. Further clinical investigation is required to fully characterize the pharmacology of such drugs.

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What is the average age someone gets hypertension?

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Hypertension is a common problem, especially in older adults and black individuals. So the key to fight hypertension is to monitor and treat hypertension in people with all age (age doesn’t define it). The most prevalent ages is between 40 to 49 years old. The key to fight hypertension may be the diet and exercise habits.

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Is selexipag safe for people?

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selexipag is well tolerated in the short term in people irrespective of baseline blood pressure. The study will examine the impact and safety of selexipag in people with hypertension over a greater period of time.

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