NCT00760266

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
451

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

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

September 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 21, 2011

Completed
Last Updated

April 4, 2011

Status Verified

March 1, 2011

Enrollment Period

7 months

First QC Date

September 25, 2008

Results QC Date

December 22, 2010

Last Update Submit

March 31, 2011

Conditions

Hypertension

Keywords

Hypertensionolder populationaliskirenhydrochlorothiazidesystolic blood pressurediastolic blood pressureamlodipine, stage 2

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4

    Baseline and Week 4

Secondary Outcomes (4)

  • Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4

    Baseline and Week 4

  • Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8

    Baseline and Week 8

  • Percentage of Responders at Week 4 and Week 8

    At 4 weeks and 8 weeks

  • Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8

    At Weeks 4 and 8

Study Arms (2)

Aliskiren/HCTZ 300/25 mg

EXPERIMENTAL
Drug: Aliskiren

HCTZ 25 mg

ACTIVE COMPARATOR
Drug: Hydrochlorothiazide

Interventions

AliskirenDRUG

Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks

Aliskiren/HCTZ 300/25 mg
HydrochlorothiazideDRUG

Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks

HCTZ 25 mg

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female outpatients, ≥ 55 years old
  • Patients with essential hypertension
  • Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood Pressure ≥ 160 mm Hg and \< 200 mm Hg
  • Patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed

You may not qualify if:

  • Office blood pressure measured by cuff (msSBP ≥ 200 mm Hg and/or msDBP ≥ 110 mm Hg) at Visits 1-5
  • History or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
  • History of hypertensive encephalopathy or heart failure (New York Heart Association \[NYHA\] Class II-IV)
  • Cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1
  • Serum sodium less than the lower limit of normal, serum potassium \< 3.5 mEq/L (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 5 mIU/mL)
  • Use of other investigational drugs within 30 days of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sites in USA

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

  • Yan JH, Jarugula V, Sabo R, Papst CC, Zhang J, Dole WP. Pharmacokinetics and pharmacodynamics of aliskiren/hydrochlorothiazide single-pill combination tablets and free combination of aliskiren and hydrochlorothiazide. J Clin Pharmacol. 2012 May;52(5):645-55. doi: 10.1177/0091270011405499. Epub 2011 Jun 9.

    PMID: 21659626DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

aliskirenHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 4, 2011

Results First Posted

January 21, 2011

Record last verified: 2011-03

Locations

US(1)