Efficacy of Rostafuroxin in the Treatment of Essential Hypertension

Sigma-Tau Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Essential Hypertension

Treatments: Drug: Rostafuroxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00415038

PST2238-DM-03-010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 438 patients

Sex: All

Ages: 30 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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438 participants in 5 patient groups

Rostafuroxin 50 micrograms capsules

Experimental group

Description:

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

Treatment:

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Rostafuroxin 150 micrograms capsules

Experimental group

Description:

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

Treatment:

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Rostafuroxin 500 micrograms capsules

Experimental group

Description:

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

Treatment:

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Rostafuroxin 1.5 mg capsules

Experimental group

Description:

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

Treatment:

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Rostafuroxin 5 mg capsule

Experimental group

Description:

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

Treatment:

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin

Drug: Rostafuroxin