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
  Purpose

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.


Condition Intervention Phase
Hypertension
Stage 2 Hypertension
Diabetes
Drug: Valturna
Drug: Amlodipine
Drug: Chlorthalidone
Drug: Placebo of Valturna Tablet
Drug: Placebo Capsule
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 975
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Valturna
Valturna (aliskiren 150 mg/valsartan 160 mg) tablet
Drug: Placebo of Valturna Tablet
Matching placebo of valturna tablet
Drug: Placebo Capsule
Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone 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.
Drug: Valturna
Valturna (aliskiren 150 mg/valsartan 160 mg) tablet
Drug: Amlodipine
Amlodipine 5 mg and 10 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
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.
Drug: Valturna
Valturna (aliskiren 150 mg/valsartan 160 mg) tablet
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368536

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Locations
United States, Alabama
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Athens, Alabama, United States, 35611
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Florence, Alabama, United States, 35630
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Huntsville, Alabama, United States, 35801
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

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

Keywords provided by Novartis:
High blood pressure
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Chlorthalidone
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Vasodilator Agents

ClinicalTrials.gov processed this record on August 21, 2014