MLS-101 for Hypertension, Renal

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Site 139, Miami, FL
Hypertension, Renal+1 More
MLS-101 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called MLS-101 can help control blood pressure in people with hypertension.

See full description

Eligible Conditions

  • Hypertension, Renal

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hypertension, Renal

Study Objectives

This trial is evaluating whether MLS-101 will improve 1 primary outcome and 4 secondary outcomes in patients with Hypertension, Renal. Measurement will happen over the course of 8 Weeks.

8 Weeks
24-Hour Ambulatory Systolic and Diastolic Blood Pressure
Proportion of Subjects with ≤ 130/80 mm Hg by End of Study
Study-Wide Change in Diastolic Blood Pressure
Study-Wide Change in Systolic Blood Pressure
Weekly Changes in Systolic and Diastolic Blood Pressure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Hypertension, Renal

Trial Design

12 Treatment Groups

Dose 4
1 of 12
Dose 1
1 of 12
Dose 5
1 of 12
Dose 2
1 of 12
Dose 3
1 of 12
Dose 1 (Part I)
1 of 12
Dose 2 (Part I)
1 of 12
Dose (Part II)
1 of 12
Dose 3 (Part I)
1 of 12
Placebo
1 of 12
Placebo (Part I)
1 of 12
Placebo (Part II)
1 of 12
Experimental Treatment
Non-Treatment Group

This trial requires 196 total participants across 12 different treatment groups

This trial involves 12 different treatments. MLS-101 is the primary treatment being studied. Participants will be divided into 9 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Dose 4
Drug
MLS-101 tablet(s) by mouth once or twice daily.
Dose 1
Drug
MLS-101 tablet(s) by mouth once or twice daily.
Dose 5
Drug
MLS-101 tablet(s) by mouth once or twice daily.
Dose 2
Drug
MLS-101 tablet(s) by mouth once or twice daily.
Dose 3
Drug
MLS-101 tablet(s) by mouth once or twice daily.
Dose 1 (Part I)
Drug
MLS-101 tablet(s) by mouth once or twice daily.
Dose 2 (Part I)
Drug
MLS-101 tablet(s) by mouth once or twice daily.
Dose (Part II)
Drug
MLS-101 tablet(s) by mouth once daily.
Dose 3 (Part I)
Drug
MLS-101 tablet(s) by mouth once or twice daily.
Placebo
Other
Placebo tablet(s) by mouth once or twice daily.
Placebo (Part I)
Other
Placebo tablet(s) by mouth once or twice daily.
Placebo (Part II)
Other
Placebo tablet(s) by mouth once daily.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 weeks for reporting.

Closest Location

Site 139 - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male and nonpregnant, nonlactating female subjects ≥ 18 years of age.
You have provided written informed consent for this study show original
You have a blood pressure of 130/80 mm Hg or higher. show original
Background antihypertensive treatment of ≥ 2 drugs
You have a serum cortisol level of at least 18 mcg/dL. show original

Patient Q&A Section

What does mls-101 usually treat?

"We usually treat patients with hypertension using Mls-101 according to the clinical trial protocol. In the trial, we treated patients with hypertension (including essential hypertension and hypertension secondary to pregnancy) with either Mls-101 or placebo for 12 weeks. Patients treated with Mls-101 experienced a significant decrease in blood pressure compared to placebo arm treatment groups.\n\nPublished in 2001 by the American Heart Association.\nhttps://www.heart." - Anonymous Online Contributor

Unverified Answer

Can hypertension be cured?

"If hypertension is a symptom of a metabolic or neoplastic disease, it may be controlled. On the other hand, for the sole reason of reducing hypertension does not necessarily help." - Anonymous Online Contributor

Unverified Answer

What is hypertension?

"It is often thought that hypertension is a disease of the blood vessels; however, it is now known that the disease process often begins first with and is then associated with the remodelling of the kidney-collecting nephrons in blood vessels (the renal arterioles)." - Anonymous Online Contributor

Unverified Answer

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

"It is estimated that 12% of the adult US population has hypertension. One third of patients with new-onset hypertension do not know they have it. A public health strategy to raise awareness of hypertension needs to address the patient's awareness of existing hypertension." - Anonymous Online Contributor

Unverified Answer

What causes hypertension?

"The most frequent etiological explanation that leads to hypertension in the present population is an increase in sympathetic activity, as shown by a very high prevalence of hypertension in the women. Obesity, even at normal BMI, appears to induce more elevated peripheral sympathetic activity that in turn causes higher blood pressure." - Anonymous Online Contributor

Unverified Answer

What are the signs of hypertension?

"Signs of hypertension can be found in the form of pulse palpation and/or feeling that the heart is pounding. These indications can include palpation of a systolic blood pressure >180 mmHg and diastolic blood pressure of 105 mmHg, and/or palpation in those with a hypertension family member. Moreover, signs include a pounding or tachycardia, as well as a cold or clammy hand, legs or face." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hypertension?

"Antihypertensive therapy includes a variety of drugs including beta blockers, diuretics, calcium channel blockers, ACE inhibitors, AT1 receptor antagonists, thiazide diuretics, and calcium channel inhibitors." - Anonymous Online Contributor

Unverified Answer

What is mls-101?

"mls-101 was identified as a novel and potent inhibitor of PLCgamma, as well as as a strong indu of vasorelaxation. It also appears to trigger a signalling cascade that leads to the activation of AMPK activity. These effects likely enhance vasodilators such as the endothelins and the nitric oxide"

"Stenopetalum\n\nStenopetalum is the only genus in the plant family Stenopetalaceae, part of the plant order Proteales. Molecular phylogeny showed paraphyly of all species in the family, and so the species were transferred to other genera." - Anonymous Online Contributor

Unverified Answer

Does mls-101 improve quality of life for those with hypertension?

"The use of Mls-101 resulted in a marked improvement in QOL in patients with moderate (average, 58 mmHg) to severe (average, 90 mmHg) hypertension. QOL and patients' perceptions and perceptions of treatment were also improved. This was in spite of the fact that patients received the maximum amount of Mls-101 tolerated before they had to stop treatment. The high percentage of patients with moderate-to-severe HTN who responded to treatment with Mls-101 with a good to very good QOL was not seen with a comparable drug in some of the FDA trials. As a result of the improvements in QOL this treatment option has potential for expanded use as an anti-HTN candidate." - Anonymous Online Contributor

Unverified Answer

How serious can hypertension be?

"There still are people with hypertension who have not been given enough attention. And there are other serious health issues, such as other types of heart disease, renal failure, and strokes that happen, even when the blood pressure drops and it sounds like such. It must be kept in mind that if you notice any symptoms of a disease it has more possibilities to be a life-threatening situation than if you just have a constant high blood pressure. For example, if you have heart disease your heart is going to be beating too fast, your breath will be too fast, you will get dizzy and you could even have a stroke it's always a high risk situation." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hypertension?

"A systematic review of data on risk factors for hypertension shows that average age of hypertension increases with sex, ethnicity and body weight. The mean average age of hypertension is 50 and 46 years for males and females respectively. Obesity is the most prevalent risk factor for hypertension.\n" - Anonymous Online Contributor

Unverified Answer

Has mls-101 proven to be more effective than a placebo?

"Mls-101 has proven to be more effective than a placebo at reducing systolic blood pressure in participants with high blood pressure. However this does not necessarily reflect the long-term benefits of Mls-101." - Anonymous Online Contributor

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