None listed
Conditions
Interventions
Group 1 Type of group
After 4 weeks of treatment with placebo patients will receive 100 mg of ecopipam VO for 52 weeks
Group name:Group 2 Type of group
After 4 weeks with placebo treatment Placebo VO will continue to be administered for 52 weeks
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • If the subject has a diagnosis of hypertension, it should have been maintained with stable doses of permitted antihypertensive agents for at least 60 days before the Selection (Week -4). Diagnosis and treatment must conform to the WHO Guidelines for the Care of Hypertension of 1999 (1999 WHO Guidelines for Management of Hypertension). • If the subject has a diagnosis of hypertension, the systolic pressure with treatment should be 27 and <45 in the measurement made in the Selection {Week -4). • The subject must be able to understand and accept to give written informed consent, as well as be able to meet the requirements of the study. • Women should not be breastfeeding or able to conceive (that is, they should be sterile because they have undergone a hysterectomy or a bilateral tubal ligation, or have been postmenopausal for at least a year) or, if they can conceive, accept the use of effective barrier contraceptive methods, use an intrauterine device (IUD), birth control pills or an equivalent injectable contraceptive. The patient must have been using the contraceptive method selected for at least three months before the Selection (Week - 4).
Exclusion criteria
Exclusion criteria: • Systolic pressure> 160 mmHg in the Selection or randomization. • Diastolic pressure> 100 mmHg in the Selection or randomization. • Fasting triglyceride levels> 700 mg / dl. • Fasting LDL-C levels> 200 mg / dl. • History of ongoing severe or unstable medical condition (eg, major recent surgery, myocardial infarction or acute cardiovascular event within six months of Screening, history of malignancy [with the exception of basal cell carcinoma or cell carcinoma] squamous skin and cervical carcinoma in situ]) Parkinson´s disease, history of seizures, neutropenia (neutrophils 500 msec or family history of severe cardiac dysrhythmias. • Congestive heart failure (Ciase III or IV in the NYHA classification). • History of pulmonary hypertension. • Peripheral vascular disease unstable or that produces pain in moments of rest. • Prior amputation due to peripheral vascular disease. • Antecedent or current diagnosis of a psychiatric disorder (criteria of the DSM-IV [Diagnostic and Statistical Manual of Mental Disorders]). • Known antecedents of alcohol dependence or drugs or current drug or alcohol abuse (DSM-IV criteria). • Reports of unstable weight loss within the six months prior to the Selection. • History of anorexia nervosa or bulimia (diagnosed according to DSM-IV). • Bariatric surgery performed or elective bariatric surgery projected for next year. • Obesity due to an identifiable endocrinological or metabolic syndrome, such as the Cushing, Prader-Willi or Laurence-Moon-Biedl syndromes. • Replacement hormone therapy started within 90 days of the Selection (Week -4). • administration of a prohibited medication within 60 days prior to the Selection (Week -4) • Clinical laboratory tests (eg, blood chemistry and urinalysis) that are outside of normal values ​​and that the researcher or Sponsor considers clinically unacceptable. • Serum creatinine levels greater than 1.4 mg / dl (in women) and 1.5 mg / dl (in men). • Abnormal TSH levels (with or without treatment and with respect to normal laboratory values). • Transaminase levels> 3 x ULN (the upper normal limit). • Pregnancy or breast-feeding. • Consent previously signed to participate in a clinical study with ecopipam. • Housing shared with a person who is participating in a clinical study with ecopipam. • Participation in any clinical study (research protocol) or administration of an investigational drug, other than prohibited drugs, within 30 days before the Selection (Week -4). • Known hypersensitivity to any of the excipients. • Re
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Proportion of subjects that have dropped between 5% and 10% of weight since the randomization Measure:Distribution of the percentage of weight loss achieved after one year of treatment Timepoints:12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of blood pressure Measure:Average modification produced in the systolic pressure Timepoints:at the end of treatment and at each visit with respect to randomization (Day 1) ; Outcome name:Measurement of blood pressure Measure:Average modification produced in the diastolic pressure Timepoints:at the end of treatment and at each visit with respect to randomization (Day 1) ; Outcome name:Lipid profile: total cholesterol (TC), LDL-C, HDL-C, triglycerides, TC to HDL-C ratio, VLDL and apolipoprotein B Measure:Average modification and percentage of modification produced in the following parameters: total cholesterol (TC), LDL-C, HDL-C, triglycerides, TC to HDL-C ratio, VLDL and apolipoprotein B Timepoints:at the end of treatment and at each visit with respect to randomization (Day 1) ; Outcome name:Of subjects that have fallen between 5% and 10% of weight Measure:Average weight loss (modification and percentage of modification) Timepoints:at the end of the treatment with respect to the Selection (Week -4) and to the randomization (Day 1) ; Outcome name:Both for the 5% category and the 10% for each visit. Stratification of weight loss (weight loss recorded in the selection-start period 2 kg) Measure:Proportion of subjects who responded to the treatment Timepoints:On each visit ; Outcome name:Of subjects that have fallen between 5% and 10% of weight Measure:Average weight loss (modification and percentage of modification) Timepoints:at each visit with respect to randomization (Day 1) ; Outcome name:Measurement of the circumference of the waist Measure:Average modification and percentage of modification produced in the circumference of the waist Timepoints:at the end of the treatment with respect to the randomization (Day 1) | — |
Outcome results
None listed