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Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

NCT00705575 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2011-05-30

Study results available
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Summary

This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.

Conditions

Interventions

DRUG

Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)

During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.

DRUG

Aliskiren (300 mg)

During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States
  • Argentina
  • Ecuador
  • Germany
  • Guatemala
  • Italy
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT00705575 on ClinicalTrials.gov