NCT01368536 (VALENCIA) is a Phase 4 clinical trial of Valturna in Hypertension, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01368536?

NCT01368536 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01368536?

Interventions in NCT01368536: Valturna, Amlodipine, Chlorthalidone, Placebo of Valturna Tablet, Placebo Capsule.

What condition does NCT01368536 study?

NCT01368536 studies Hypertension, Stage 2 Hypertension, Diabetes.

Is NCT01368536 still recruiting?

NCT01368536 is currently terminated. Last updated 18 March 2013.

Are results published for NCT01368536?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-03-18 · How we verify

NCT01368536: VALENCIA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 4 Results posted Last updated 18 March 2013

What this trial tests

Phase 4 trial testing Valturna in Hypertension in 975 participants. Terminated before completion.

Timeline

1 May 2011

Primary endpoint
1 February 2012

1 February 2012

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	975
Start date	1 May 2011
Primary completion	1 February 2012
Estimated completion	1 February 2012
Sites	97 locations across United States, Puerto Rico

Drugs / interventions tested

Valturna — full drug profile →
Amlodipine (amlodipine) — full drug profile →
Chlorthalidone — full drug profile →
Placebo of Valturna Tablet — full drug profile →
Placebo Capsule

Conditions studied

Hypertension — all drugs for Hypertension →
Stage 2 Hypertension — all drugs for Stage 2 Hypertension →
Diabetes — all drugs for Diabetes →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Hypertension or Stage 2 Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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
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 me

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Hypertension

Currently open trials in the same condition.

NCT07413159 — The "Check, Monitor, Control Hypertension" Study is a 24-month Randomized Trial in Houston Targeting African Americans A · NA · recruiting
NCT07361276 — Observational Study That Will Evaluate Treatment Patterns in the Management of Hypertension in the Public Primary Care S · recruiting
NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07238400 — Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia · Phase 2 · recruiting
NCT07135505 — Early Time-Restricted Eating in Older Adults With Hypertension · NA · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01368536 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 18 March 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01368536.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing