NCT00387517

Brief Summary

The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
726

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_3 hypertension

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

October 11, 2006

Last Update Submit

February 3, 2017

Conditions

Hypertension

Keywords

Diastolicsystolichypertensionaliskirenblood pressurehydrochlorothiazideHCTZ

Outcome Measures

Primary Outcomes (1)

  • Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.

Secondary Outcomes (3)

  • Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8

  • Safety and tolerability

  • Proportion of patients achieving a blood pressure control target at week 8

Interventions

Aliskiren/HCTZDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female outpatients 18 years old or older.
  • Patients with a diagnosis of hypertension defined as follows:
  • Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= mmHg and \< 110 mmHg at Visit 1.
  • All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= 85 mmHg and \< 110 mmHg at Visit 2.
  • All patients must have a msDBP \>= 90 mmHg and \< 110 mmHg at Visit 5.
  • Patients who are eligible and consent to participate in the study

You may not qualify if:

  • Severe hypertension (msDBP \>= 110 mmHg and/or MSSBP \>=180 mmHg).
  • Previous or current diagnosis of heart failure.
  • History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Unknown Facility

Investigative Centers, Germany

Location

Related Publications (1)

  • Blumenstein M, Romaszko J, Calderon A, Andersen K, Ibram G, Liu Z, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/hydrochlorothiazide (HCT) single-pill combinations in patients who are non-responsive to HCT 25 mg alone. Curr Med Res Opin. 2009 Apr;25(4):903-10. doi: 10.1185/03007990902804158.

    PMID: 19245300RESULT

MeSH Terms

Conditions

HypertensionHeart MurmursSystolic Murmurs

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2006

First Posted

October 13, 2006

Study Start

October 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(1)DE(1)