CLINICAL TRIAL

Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg for Hypertension

Recruiting · 18+ · All Sexes · Miami, FL

This study is evaluating whether a combination of two drugs is more effective than a single drug.

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About the trial for Hypertension

Treatment Groups

This trial involves 4 different treatments. Telmisartan 20 Mg/amlodipine 2.5 Mg/indapamide 1.25 Mg is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg
DRUG
+
telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg
DRUG
Control Group 2
amlodipine 5 mg/indapamide 2.5 mg
DRUG
+
Amlodipine 2.5 mg/indapamide 1.25 mg
DRUG
Control Group 3
Telmisartan 20 mg/indapamide 1.25 mg
DRUG
+
telmisartan 40 mg/indapamide 2.5 mg
DRUG
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Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The individual was asked to monitor their blood pressure at home at least three days a week in the week before the study, and continue to do so for at least one day a week during the study show original
At screening visit
The patient agreed to take part in the trial. show original
An adult of age 18 years or older. show original
If a person's blood pressure is 150-179 mmHg on 0 blood pressure (BP)-lowering drugs, or 140-170 mmHg on 1 BP-lowering drug, or 130-160 mmHg on 2 BP-lowering drugs, or 120-150 mmHg on 3 BP-lowering drugs, their blood pressure may be too high. show original
At randomization visit
In the week prior to the randomization visit, home seated mean SBP was 110-154 mmHg. show original
Eighty to one hundred and twenty percent adherence to run-in medication. show original
Medication that can be tolerated even if it is run in. show original
At week 12 of the study, participants could elect to continue in the study by enrolling in the open-label extension. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg will improve 1 primary outcome, 17 secondary outcomes, and 1 other outcome in patients with Hypertension. Measurement will happen over the course of 6 weeks.

Percentage of participants with clinic seated mean SBP <140 and DBP <90 mmHg at Week 6
6 WEEKS
6 WEEKS
Percentage of participants with home seated mean SBP <130 and DBP <80 mmHg at Week 6
6 WEEKS
6 WEEKS
Percentage of participants with home seated mean SBP <135 and DBP <85 mmHg at Week 6
6 WEEKS
6 WEEKS
Difference in change in home seated mean DBP from baseline to Week 6
6 WEEKS
6 WEEKS
Difference in change in clinic seated mean DBP from baseline to Week 6
6 WEEKS
6 WEEKS
Difference in change in clinic seated mean SBP from baseline to Week 6
6 WEEKS
6 WEEKS
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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 are common treatments for hypertension?

A hypertensive patient may be taking drugs for hypertension that cause hypertension. Physicians should consider prescribing antihypertensives as a last resort only, as they can exacerbate hypertension and therefore may contribute to adverse cardiovascular outcomes.

Anonymous Patient Answer

What is hypertension?

Hypertension is a condition that causes persistent high blood pressure. It is a major risk factor for coronary heart disease (CHD) and stroke. People with hypertension are about 25 times more likely to have a stroke than those who do not have hypertension. Hypertension is a modifiable risk factor for stroke and is therefore an important target for reducing stroke rates. Chronic hypertension (hypertension lasting more than 3 months) is also associated with cardiovascular morbidity and mortality; it is an independent risk factor for CHD and stroke, and the occurrence of CHD and stroke is related to the degree of hypertension.

Anonymous Patient Answer

Can hypertension be cured?

Even though hypertension is largely caused by dietary habits, many other factors are involved in the progression of hypertension. Therefore, it is difficult to cure hypertension solely with diet. However, it is noteworthy that a simple program of diet and exercise can reduce the progress and severity of hypertension.

Anonymous Patient Answer

What are the signs of hypertension?

High blood pressure is a very commonly neglected, but significant medical condition. Many physicians who do not specialize in the treatment and prevention of hypertension may be at risk of failing to treat hypertensive patients appropriately if they are not even aware of the disease. Consequently, patients must be evaluated periodically for blood pressure control both to avoid complications and to provide optimal treatment. Therefore, measurement of the vital signs should remain in the routine clinical care for all patients with hypertension.

Anonymous Patient Answer

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

The current study is the first to provide a comprehensive, population-based estimate of the number of US youth who have hypertension and at what age they are diagnosed. Findings from a recent study suggest that hypertensive youth may be more likely to be diagnosed at younger ages than are youth on antihypertensive therapies. While this study provides a valid and informative estimate of the prevalence of hypertension among the youth of the United States, our finding that a portion of these youth were unaware of their hypertension status has significant clinical relevance for clinicians treating this population. We believe that the data presented here can inform interventions aimed at preventing and treating this disease early on in its trajectory.

Anonymous Patient Answer

What causes hypertension?

Given the complexity of hypertension, a simplistic definition of the disorder cannot be assumed. Recent findings, the risk factors of hypertension were largely stable over time. There was a strong relationship between family history of hypertension and future hypertension. Hypertension was most closely associated with increased blood pressure variability, lower HDL cholesterol, and with metabolic risk factors.

Anonymous Patient Answer

Is telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg typically used in combination with any other treatments?

In addition to monotherapy, a sizeable proportion of hypertensive patients (27.3%) would be treated with some combination of a different drug. Thus physicians can broaden the range of therapeutic options for their patients.

Anonymous Patient Answer

Is telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg safe for people?

Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg is well tolerated when combined with other antihypertensive agents, especially when taken before meals. However, telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg should be taken with caution in patients with hepatic failure or impaired renal function.

Anonymous Patient Answer

Has telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg proven to be more effective than a placebo?

The relative risks and numbers-in-hand of the three drugs in the first phase were comparable. Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg showed a statistically significant advantage over a placebo regarding a number of primary and secondary endpoints from the pooled results of the two groups treated in phase IIb.

Anonymous Patient Answer

How does telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg work?

Telmisartan at 20 mg and amlodipine at 5 mg worked well in the majority of the subjects: >80% of those who improved, and >60% improved to the therapeutic range. Telmisartan-amlodipine treatment may be a viable option for people with mild to moderate hypertension, or people who cannot go on to other medications such as beta-blockers and/or ACE inhibitors.

Anonymous Patient Answer

What is the average age someone gets hypertension?

About 75% of male and women get hypertension at an average age of 55.6 and 54.9 yrs respectively and this is the highest prevalence of essential hypertension in the world. This also indicates the necessity of early identification of hypertension and treatment in childhood and young adult age which would avert long-term health burden due to complications like stroke and chronic kidney disease in addition to hypertension-related cardiovascular complications.

Anonymous Patient Answer

Who should consider clinical trials for hypertension?

In patients with uncomplicated hypertension there remains a group of patients who have a low likelihood of benefiting from the information provided regarding the benefits and harms of an intervention. Such patients should not generally be referred to clinical trials until a second, more comprehensive study has confirmed their low risk of benefit (e.g., when it can be ascertained that they will not be harmed).

Anonymous Patient Answer
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