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A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.

NCT01056731 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2017-02-23

No results posted yet for this study

Summary

This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (\< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.

Conditions

Interventions

DRUG

Aliskiren and HCTZ

Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Venezuela

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01056731 on ClinicalTrials.gov