Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to verify the efficacy of Rostafuroxin in the treatment of essential hypertension and to determine the best effective dose to be administered in the general hypertensive population and in a subset of this population in which genetic patterns could be involved in the etiology of essential hypertension.

Detailed Description
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Elevated arterial pressure is probably the most important public health problem. about 30% of the world adult population are affected by hypertension in industrialised countries. Development of a pharmacogenomic approach to the therapy of primary hypertension give new opportunities for the treatment of hypertension. This approach consists in the identification of the genetic-molecular mechanisms responsible for hypertension in a given subset of patients, and in the development of drugs able to interfere with such mechanisms, thus leading to very selective therapeutic interventions with enhanced efficacy and reduced side effects.

Official Title
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A Double Blind, Dose Range, Placebo Controlled Study of the Effects of Rostafuroxin vs Placebo in Patients With Stable, Uncomplicated, Essential Hypertension.

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Rostafuroxin
* Drug: Rostafuroxin
* Drug: Rostafuroxin
* Drug: Rostafuroxin
* Drug: Rostafuroxin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with grade 1 or 2 of essential hypertension Less than 3 risk factors (age > 55 if male, smoking, dyslipidemia, family history of CV disease occurring before 55 years in men and 65 in women Naive patients or currently on monotherapy or one combination tablet SBP between 140 and 169 mmHg Exclusion Criteria: Atrial fibrillation or left or right VBBB Left ventricular hypertrophy Significant renal or hepatic disease Obesity > 30kg/m2 Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rostafuroxin 50 micrograms capsules<br>5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design | Drug: Rostafuroxin<br>* 1 capusle of 50 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin<br>|
| Experimental: Rostafuroxin 150 micrograms capsules<br>5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design | Drug: Rostafuroxin<br>* 1 capusle of 150 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin<br>|
| Experimental: Rostafuroxin 500 micrograms capsules<br>5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design | Drug: Rostafuroxin<br>* 1 capusle of 500 micrograms of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin<br>|
| Experimental: Rostafuroxin 1.5 mg capsules<br>5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design | Drug: Rostafuroxin<br>* 1 capusle of 1.5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin<br>|
| Experimental: Rostafuroxin 5 mg capsule<br>5 weeks, once a day capsule treatment of active drug or placebo, followed by a 5 weeks, once a day capsule treatment of placebo or active drug according to a cross-over design | Drug: Rostafuroxin<br>* 1 capusle of 5 milligrams of Rostafuroxin or placebo per day in the morning before breakfast for 5 weeks followed by other 5 weeks with placebo or Rostafuroxin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office Systolic Blood Pressure after 5 week of treatment |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office Diastolic Blood Pressure |  | 5 weeks | 
| Proportion of normalised and responder patients (all visits) |  | 5 weeks | 
| 24 hours BP monitoring (through to peak ratio) |  | 5 weeks | 
| Effect on sub-populations, genetically selected |  | 5 weeks | 
| safety of the drug |  | monitored during all the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, pharmacogenomic, adducin, ouabain, rostafuroxin