?Estudio internacional, multicéntrico, doble ciego, aleatorizado, controlado con placebo, de búsqueda de dosis para evaluar la eficacia, la seguridad y la tolerabilidad de MK-0736 añadido al tratamiento en curso con un inhibidor de la enzima convertidora de la angiotensina (IECA) o con un antagonista del receptor de la angiotensina (ARA) en pacientes con diabetes e hipertensión?A Worldwide, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of MK-0736 When Added to Ongoing Therapy With Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) in Patients With Diabetes and Hypertension - MK-0736 Dose Ranging Study

• Conditions: Hipertensión en paciente con hipertensión y diabetesHypertension in Patients with Hypertension and Diabetes; MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

• Registration Number: EUCTR2008-004831-39-ES
• Lead Sponsor: Merk & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 567

Inclusion Criteria

1. Patient is ≥18 years of age and ≤75 years of age.
2) Patient has Type II diabetes (T2DM) and:
HbA1c ≥ 7.0% and ≤ 9.0 %.
Is not newly diagnosed (within 3 months of Visit 1)
Is not taking new or recently adjusted anti-diabetic pharmacotherapy (with the exception of ±10 units of insulin) within 3 months of Visit 1.

3) A patient who is of reproductive potential agrees to remain abstinent* or use (or have their partner use) 2 acceptable methods of birth control for the duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy, and hormonal contraception.

4) At Randomization, SiSBP ≥120 mmHg and < 160 mmHg and SiDBP ≥ 85 mmHg and < 100 mmHg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Patient has a history of type 1 diabetes mellitus or history of ketoacidosis.
2) Patient has decompensated valvular disease, presence of hemodynamically significant obstructive valvular disease or cardiomyopathy.
3) Patient has a history of malignancy ≤ 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
4) Patient is human immunodeficiency virus (HIV) positive (as assessed by medical history).
5) Patient has received treatment with any investigational drugs within the past 30 days.
6) Patient does not agree to comply with restrictions on alcohol (average allowed intake of < 14 drinks per week and no alcohol intake within 24 hours prior to all clinic visits requiring fasting laboratory analysis) or patient has a history of alcohol or drug abuse within the past 3 years.
7) Patient has BMI ≥ 41 kg/m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified