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

June 6, 2011
March 18, 2013
May 2011
February 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Change from baseline in mean sitting systolic BP (MSSBP)after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Safety assessments include BP, vital signs and adverse events
Complete list of historical versions of study NCT01368536 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Sitting blood pressure (BP) was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
  • Percentage of Responders After Treatment [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg
  • Percentage of Patients Achieving Blood Pressure Control After Treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Patient with blood pressure control is defined as patients achieving MSSBP <130 mmHg and MSDBP <80 mmHg.
  • 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 ] [ Designated as safety issue: Yes ]
  • change from baseline in MSSBP after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Safety assessments include BP, vital signs and adverse events
  • Change from baseline in mean sitting diastolic BP (MSDBP) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Safety assessments include BP, vital signs and adverse events
  • Percentage of responders after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Evaluate safety and tolerability of treatment with valturna and chlorthalidone or valturna and amlodipine versus valturna alone [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Safety assessments include BP, vital signs and adverse events
Not Provided
Not Provided
 
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
A 12-week, Multi-Center, Randomized Double-Blind, Active Control Parallel Group 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

This was a study to assess the safety and efficacy of Valturna and amlodipine or Valturna and chlorthalidone when compared to Valturna alone in patients with stage 2 hypertension and diabetes mellitus 2.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Hypertension
  • Stage 2 Hypertension
  • Diabetes
  • Drug: Valturna
    Valturna (aliskiren 150 mg/valsartan 160 mg) tablet
  • Drug: Amlodipine
    Amlodipine 5 mg and 10 mg capsule
  • Drug: Chlorthalidone
    Chlorthalidone 15 mg and 25 mg capsule
  • Drug: Placebo of Valturna Tablet
    Matching placebo of valturna tablet
  • Drug: Placebo Capsule
    Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule
  • Experimental: 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.
    Interventions:
    • Drug: Valturna
    • Drug: Placebo of Valturna Tablet
    • Drug: Placebo Capsule
  • Active Comparator: 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.
    Interventions:
    • Drug: Valturna
    • Drug: Amlodipine
    • Drug: Placebo of Valturna Tablet
    • Drug: Placebo Capsule
  • Active Comparator: 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.
    Interventions:
    • Drug: Valturna
    • Drug: Chlorthalidone
    • Drug: Placebo of Valturna Tablet
    • Drug: Placebo Capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
975
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with stage 2 hypertension within protocol limits at randomization
  • Patients with type 2 diabetes mellitus with HgA1c less than or equal to 9%
  • Patients with newly diagnosed hypertension or patients who have not received antihypertensive therapy for at least 4 weeks prior to screening

Exclusion Criteria:

  • Patients taking 4 or more antihypertensive medications at screening visit
  • Patients with uncontrolled BP (> 140/90 mmHg) while taking 3 or more antihypertensives at their maximum approved doses
  • Type 2 diabetes mellitus requiring insulin treatment
  • Patients with HgA1c > 9%
  • Patients with known gout
  • Known history of cancer within the past 5 years
  • Patients who are pregnant or nursing mothers
  • Patients who have participated in an investigational clinical trial within the 30 days prior to screening.
  • Other protocol-defined inclusion/exclusion criteria may apply
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01368536
CSPV100AUS05
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP