Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes (VALENCIA)

This study has been terminated.
(Based on results from an ALTITUDE study interim analysis, testing aliskiren concomitantly with an ACE inhibitor or ARB, in diabetics with renal impairment)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01368536
First received: June 6, 2011
Last updated: March 18, 2013
Last verified: March 2013
Results First Received: February 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Hypertension
Stage 2 Hypertension
Diabetes
Interventions: Drug: Valturna
Drug: Amlodipine
Drug: Chlorthalidone
Drug: Placebo of Valturna Tablet
Drug: Placebo Capsule

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 975 patients screened, 417 were randomized.

Reporting Groups
  Description
Valturna At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
Valturna + Amlodipine At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
Valturna + Chlorthalidone At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.

Participant Flow:   Overall Study
    Valturna     Valturna + Amlodipine     Valturna + Chlorthalidone  
STARTED     138     137     142  
Full Analysis Set     138     137     141 [1]
COMPLETED     87     78     83  
NOT COMPLETED     51     59     59  
Adverse Event                 5                 6                 8  
Abnormal laboratory value(s)                 0                 1                 2  
Abnormal test procedure result(s)                 0                 0                 1  
Unsatisfactory therapeutic effect                 7                 2                 2  
No longer required study medication                 0                 0                 1  
Withdrawal by Subject                 2                 5                 4  
Lost to Follow-up                 3                 3                 5  
Administrative problems                 34                 39                 35  
Protocol deviation                 0                 3                 1  
[1] One patient was excluded from efficacy analysis as there was no post baseline data



  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
Valturna At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
Valturna + Amlodipine At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
Valturna + Chlorthalidone At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
Total Total of all reporting groups

Baseline Measures
    Valturna     Valturna + Amlodipine     Valturna + Chlorthalidone     Total  
Number of Participants  
[units: participants]
  138     137     141     416  
Age  
[units: Years]
Mean ± Standard Deviation
  54.7  ± 8.65     56.0  ± 9.56     54.6  ± 9.35     55.1  ± 9.20  
Gender  
[units: Participants]
       
Female     73     73     70     216  
Male     65     64     71     200  



  Outcome Measures
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1.  Primary:   Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone   [ Time Frame: Baseline, 12 weeks ]

2.  Secondary:   Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone   [ Time Frame: Baseline, 12 weeks ]

3.  Secondary:   Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment   [ Time Frame: Baseline, 12 weeks ]

4.  Secondary:   Percentage of Responders After Treatment   [ Time Frame: Baseline, 12 weeks ]

5.  Secondary:   Percentage of Patients Achieving Blood Pressure Control After Treatment   [ Time Frame: 12 weeks ]

6.  Secondary:   Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone   [ Time Frame: 12 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
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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.


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


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01368536     History of Changes
Other Study ID Numbers: CSPV100AUS05
Study First Received: June 6, 2011
Results First Received: February 14, 2013
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration