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 - Full Text View

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:

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Chlorthalidone Amlodipine Amlodipine besylate

U.S. FDA Resources

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

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

Show 97 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

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
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013

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)