NCT00386139

Brief Summary

Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
881

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

October 9, 2006

Last Update Submit

February 3, 2017

Conditions

Hypertension

Keywords

Diastolicsystolichypertensionaliskirenblood pressurehydrochlorothiazide, HCTZ

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.
  • Patients who are eligible and consent to participate in the study

You may not qualify if:

  • Severe hypertension
  • Previous or current diagnosis of heart failure.
  • History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).

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)

  • Nickenig G, Simanenkov V, Lembo G, Rodriguez P, Salko T, Ritter S, Zhang J. Efficacy of aliskiren/hydrochlorothiazide single-pill combinations in aliskiren non-responders. Blood Press Suppl. 2008 Dec;2:31-40. doi: 10.1080/08038020802507290.

    PMID: 19203020RESULT

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2006

First Posted

October 11, 2006

Study Start

September 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

US(1)DE(1)