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To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy (ARIA)

This study has been terminated.
(In consequence of termination of ALTITUDE. A number of studies were continued in consultation with the Altitude Data Monitoring Committee.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01302899
First Posted: February 24, 2011
Last Update Posted: January 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: December 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Non-diabetic Nephropathy
Interventions: Drug: Aliskiren
Drug: Placebo to Aliskiren
Drug: Hydrochlorothiazide (HCTZ)
Drug: Placebo to Hydrochlorothiazide (HCTZ)
Drug: Ramipril

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.

Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.

Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.

Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.

Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.

Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.


Participant Flow for 4 periods

Period 1:   Period 1 (Day 1 to End of Week 6)
    Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram   Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
STARTED   4   4 
COMPLETED   4   4 
NOT COMPLETED   0   0 

Period 2:   Period 2 (Weeks 7 to 12)
    Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram   Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
STARTED   4   4 
COMPLETED   3   3 
NOT COMPLETED   1   1 
Protocol Deviation                1                0 
Abnormal laboratory value(s)                0                1 

Period 3:   Period 3 (Weeks 13 to 18)
    Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram   Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
STARTED   3   3 
COMPLETED   3   3 
NOT COMPLETED   0   0 

Period 4:   Period 4 (Weeks 19 to 26)
    Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram   Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
STARTED   3   3 
COMPLETED   3   3 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.

Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.

Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram

Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.

Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.

Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.

Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Total Total of all reporting groups

Baseline Measures
   Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram   Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.5  (6.76)   58.5  (8.70)   54.5  (8.38) 
Gender 
[Units: Participants]
     
Female   2   1   3 
Male   2   3   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effect of Aliskiren on Albuminuria as Measured by Urinary Albumin Excretion Rate (UAER)   [ Time Frame: 26 weeks ]

2.  Primary:   Effect of Aliskiren on Albuminuria as Measured by Creatinine Indexed Albumin   [ Time Frame: 26 weeks ]

3.  Secondary:   Mean Sitting Systolic Blood Pressure (msSBP)   [ Time Frame: 26 weeks ]

4.  Secondary:   Mean Sitting Diastolic Blood Pressure (msDBP)   [ Time Frame: 26 weeks ]

5.  Secondary:   Mean Glomerular Filtration Rate (GFR) as Measurement of Renal Function   [ Time Frame: 26 weeks ]

6.  Secondary:   Mean Effective Renal Plasma Flow (ERPF) as One of Hemodynamic Assessments   [ Time Frame: 26 weeks ]

7.  Secondary:   Percentage of Renal Filtration Fraction (RFF) as One of Hemodynamic Assessments   [ Time Frame: 26 weeks ]

8.  Secondary:   Mean Extracellular Volume (ECV) as One of Hemodynamic Assessments   [ Time Frame: 26 weeks ]

9.  Secondary:   Plasma Rennin Activity (PRA)   [ Time Frame: Baseline to week 26 ]

10.  Secondary:   Plasma Rennin Concentration (PRC)   [ Time Frame: Baseline to week 26 ]

11.  Secondary:   Number of Participants With Adverse Events, Serious Adverse Events and Death as Assessment of Safety and Tolerability of Aliskiren Added to Ramipril   [ Time Frame: 26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01302899     History of Changes
Other Study ID Numbers: CSPP100A2260
2009-012196-10 ( EudraCT Number )
First Submitted: February 9, 2011
First Posted: February 24, 2011
Results First Submitted: December 21, 2012
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013