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

NCT01368536 | Terminated Phase 4 Results

• 1 other identifier: CSPV100AUS05
• Study Type: interventional
• Target: 975
• Locations: 2 countries
• Sites: 97

Brief Summary

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.

Conditions

Hypertension; Stage 2 Hypertension; Diabetes

Keywords

High blood pressure; diabetes

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline, 12 weeks

Secondary Outcomes (5)

• Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone

  Baseline, 12 weeks

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment

  Baseline, 12 weeks

• Percentage of Responders After Treatment

  Baseline, 12 weeks

• Percentage of Patients Achieving Blood Pressure Control After Treatment

  12 weeks

• 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

  12 weeks

Study Arms (3)

Valturna

EXPERIMENTAL

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; Drug: Placebo of Valturna Tablet; Drug: Placebo Capsule

Valturna + Amlodipine

ACTIVE COMPARATOR

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; Drug: Amlodipine; Drug: Placebo of Valturna Tablet; Drug: Placebo Capsule

Valturna + chlorthalidone

ACTIVE COMPARATOR

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; Drug: Chlorthalidone; Drug: Placebo of Valturna Tablet; Drug: Placebo Capsule

Interventions

Valturna DRUG

Valturna (aliskiren 150 mg/valsartan 160 mg) tablet

Valturna; Valturna + Amlodipine; Valturna + chlorthalidone

Amlodipine DRUG

Amlodipine 5 mg and 10 mg capsule

Valturna + Amlodipine

Chlorthalidone DRUG

Chlorthalidone 15 mg and 25 mg capsule

Valturna + chlorthalidone

Placebo of Valturna Tablet DRUG

Matching placebo of valturna tablet

Valturna; Valturna + Amlodipine; Valturna + chlorthalidone

Placebo Capsule DRUG

Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule

Valturna; Valturna + Amlodipine; Valturna + chlorthalidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (97)

Novartis Investigative Site

Athens, Alabama, 35611, United States

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Novartis Investigative Site

Florence, Alabama, 35630, United States

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Huntsville, Alabama, 35801, United States

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Montgomery, Alabama, 36106, United States

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Muscle Shoals, Alabama, 35662, United States

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Chandler, Arizona, 85224, United States

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Little Rock, Arkansas, 72204, United States

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Buena Park, California, 90620, United States

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Fair Oaks, California, 95628, United States

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Fresno, California, 93726, United States

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Healdsburg, California, 95448, United States

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Los Angeles, California, 90057, United States

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Orangevale, California, 95662, United States

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Riverside, California, 92506, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95816, United States

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Santa Ana, California, 92701, United States

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West Covina, California, 91790, United States

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Shelton, Connecticut, 06484, United States

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Fort Lauderdale, Florida, 33306, United States

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Fort Lauderdale, Florida, 33308, United States

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Jupiter, Florida, 33458, United States

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Lauderdale Lakes, Florida, 33319, United States

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North Miami Beach, Florida, 33169, United States

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St. Petersburg, Florida, 33701, United States

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Tampa, Florida, 33603, United States

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West Palm Beach, Florida, 33409, United States

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Augusta, Georgia, 30904, United States

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Honolulu, Hawaii, 96813, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60610, United States

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Chicago, Illinois, 60617, United States

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Gurnee, Illinois, 60031, United States

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Lansing, Kansas, 66043, United States

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Topeka, Kansas, 66606, United States

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Beltsville, Maine, 20705, United States

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Waltham, Massachusetts, 02453, United States

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Wellesley Hills, Massachusetts, 02481-2106, United States

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Brooklyn Center, Minnesota, 55430-2168, United States

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Belzoni, Mississippi, 39038, United States

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Jackson, Mississippi, 39209, United States

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Picayune, Mississippi, 39466, United States

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Kansas City, Missouri, 64111, United States

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Ozark, Missouri, 65721, United States

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St Louis, Missouri, 63110-1093, United States

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St Louis, Missouri, 63128, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Henderson, Nevada, 89014, United States

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Las Vegas, Nevada, 89119, United States

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Toms River, New Jersey, 08753, United States

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Toms River, New Jersey, 08755, United States

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Trenton, New Jersey, 08629, United States

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Buffalo, New York, 14209, United States

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Camillus, New York, 13031, United States

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Asheboro, North Carolina, 27204, United States

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Asheville, North Carolina, 28801, United States

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Greensboro, North Carolina, 27401, United States

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Greensboro, North Carolina, 27408, United States

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Shelby, North Carolina, 28150, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58103, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45224, United States

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Columbus, Ohio, 43201, United States

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Lyndhurst, Ohio, 44124, United States

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Zanesville, Ohio, 43701, United States

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Oklahoma City, Oklahoma, 73132-4904, United States

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Oklahoma City, Oklahoma, 73134, United States

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Portland, Oregon, 97232, United States

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Reading, Pennsylvania, 19609, United States

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Uniontown, Pennsylvania, 15401, United States

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Wallingford, Pennsylvania, 19086, United States

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Charleston, South Carolina, 29407, United States

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Charleston, South Carolina, 29412, United States

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Easley, South Carolina, 29640, United States

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Greenville, South Carolina, 29615, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Summerville, South Carolina, 29485, United States

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Varnville, South Carolina, 29944, United States

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Fayetteville, Tennessee, 33734, United States

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Novartis Investigative Site

Arlington, Texas, 76012, United States

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Novartis Investigative Site

Austin, Texas, 78728-6904, United States

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Novartis Investigative Site

Austin, Texas, 78735, United States

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Novartis Investigative Site

Dallas, Texas, 75235, United States

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Novartis Investigative Site

Houston, Texas, 77025, United States

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Novartis Investigative Site

Houston, Texas, 77074, United States

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Novartis Investigative Site

Houston, Texas, 77081, United States

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Novartis Investigative Site

Houston, Texas, 77083, United States

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Novartis Investigative Site

Lake Jackson, Texas, 77566, United States

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Novartis Investigative Site

Pasadena, Texas, 77504, United States

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Plano, Texas, 75093, United States

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Richardson, Texas, 75080, United States

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St. George, Utah, 84790, United States

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Arlington, Virginia, 22203, United States

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Carolina, 00983, Puerto Rico

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Novartis Investigative Site

San Juan, 00926, Puerto Rico

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MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

Amlodipine; Chlorthalidone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 8, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 21, 2013
• Results First Posted: March 19, 2013

Record last verified: 2013-03

Locations

PR (2); US (95)