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)

Novartis

Status and phase: Terminated; Phase 4

Conditions: Hypertension; Diabetes; Stage 2 Hypertension

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01368536

CSPV100AUS05

Details and patient eligibility

About

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.

Enrollment: 975 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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975 participants in 3 patient groups

Valturna

Experimental group

Description:

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.

Treatment:

Drug: Placebo of Valturna Tablet

Drug: Valturna

Drug: Placebo Capsule

Valturna + Amlodipine

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo of Valturna Tablet

Drug: Valturna

Drug: Amlodipine

Drug: Placebo Capsule

Valturna + chlorthalidone

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo of Valturna Tablet

Drug: Valturna

Drug: Chlorthalidone

Drug: Placebo Capsule