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Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus (ViVID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00927394
First received: June 24, 2009
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
Results First Received: October 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Aliskiren
Drug: Valsartan
Drug: Placebo for Aliskiren
Drug: Placebo for Valsartan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Combination Therapy: Aliskiren + Valsartan To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
Monotherapy: Valsartan To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.

Participant Flow:   Overall Study
    Combination Therapy: Aliskiren + Valsartan     Monotherapy: Valsartan  
STARTED     575     568 [1]
Cohort 1 (Randomized)     157 [2]   165  
Cohort 2 (Randomized)     418 [3]   403  
Combined Safety Set (Cohort 1 and 2)     574     565  
Cohort 1: Full Analysis Set 1 (FAS 1)     157 [4]   164  
Cohort 2: Full Analysis Set 2 (FAS 2)     417 [5]   398  
FAS 2 :Ambulatory Blood Pressure Monitor     342 [6]   323  
Combined Full Analysis Set (FAS 1+FAS 2)     574     562  
COMPLETED     498     483  
NOT COMPLETED     77     85  
Adverse Event                 14                 9  
Unsatisfactory therapeutic effect                 17                 23  
Withdrawal by Subject                 20                 24  
Lost to Follow-up                 8                 14  
Administrative Problem                 1                 0  
Death                 1                 1  
Protocol deviation                 16                 13  
Randomized in error                 0                 1  
[1] One patient was randomized in error and was discontinued by site.
[2] Cohort 1 includes patients with specific eligibility criteria mentioned in protocol section
[3] Cohort 2 includes patients with specific eligibility criteria mentioned in protocol section
[4] FAS 1 includes all patients in Cohort 1 to whom study treatments were given through randomization.
[5] FAS 2= all patients randomized to Cohort 2 and who had a valid baseline assessment of 24 hours ABPM.
[6] consists of all patients in FAS 2 who had both valid baseline and post-baseline ABPM assessments.



  Baseline Characteristics
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Reporting Groups
  Description
Combination Therapy: Aliskiren + Valsartan To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
Monotherapy: Valsartan To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
Total Total of all reporting groups

Baseline Measures
    Combination Therapy: Aliskiren + Valsartan     Monotherapy: Valsartan     Total  
Number of Participants  
[units: participants]
 		  574     565     1139  
Age [1]
[units: years]
Mean ± Standard Deviation 		  55.0  ± 9.30     55.2  ± 9.60     55.1  ± 9.44  
Gender  
[units: participants]
 		     
Female     233     244     477  
Male     341     321     662  
[1] Demographic measures were based on Safety set.



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8   [ Time Frame: baseline, week 8 ]
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2.  Secondary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)   [ Time Frame: Baseline, week 8 ]
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3.  Secondary:   Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8   [ Time Frame: baseline, week 8 ]
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4.  Secondary:   Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8   [ Time Frame: baseline, week 8 ]
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5.  Secondary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)   [ Time Frame: Baseline, week 8 ]
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6.  Secondary:   Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8   [ Time Frame: baseline, week 8 ]
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7.  Secondary:   Percentage of Patients Achieving Blood Pressure Control   [ Time Frame: 8 weeks ]
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8.  Secondary:   Percentage of Responders   [ Time Frame: Baseline, Week 8 ]
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9.  Secondary:   Change From Baseline in Plasma Renin Activity (PRA) at Week 8   [ Time Frame: Baseline, week 8 ]
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10.  Secondary:   Change From Baseline in Plasma Renin Concentration (PRC) at Week 8   [ Time Frame: Baseline, week 8 ]
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11.  Secondary:   Change From Baseline in Plasma Aldosterone at Week 8   [ Time Frame: Baseline, week 8 ]
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12.  Secondary:   Number of Patients With Adverse Events, Serious Adverse Events and Death   [ Time Frame: 8 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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
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Results Point of Contact:  
Name/Title: Study Directors
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00927394     History of Changes
Other Study ID Numbers: CSPV100AUS02
Study First Received: June 24, 2009
Results First Received: October 1, 2012
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration